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1. Deep learning model to identify and validate hypotension endotypes in surgical and critically ill patients.

Author

Jian, Zhongping, Liu, Xianfu, Kouz, Karim, Settels, Jos, Davies, Simon, Scheeren, Thomas, Fleming, Neal, Veelo, Denise, Vlaar, Alexander, Sander, Michael, Cannesson, Maxime, Berger, David, Pinsky, Michael, Sessler, Daniel, Hatib, Feras, and Saugel, Bernd

Subjects
anaesthesia, blood pressure, cardiac output, haemodynamic monitoring, hypotension, machine learning, Humans, Hypotension, Critical Illness, Deep Learning, Female, Male, Middle Aged, Aged, Algorithms, Adult, Stroke Volume, Heart Rate, Vascular Resistance
Abstract

BACKGROUND: Hypotension is associated with organ injury and death in surgical and critically ill patients. In clinical practice, treating hypotension remains challenging because it can be caused by various underlying haemodynamic alterations. We aimed to identify and independently validate endotypes of hypotension in big datasets of surgical and critically ill patients using unsupervised deep learning. METHODS: We developed an unsupervised deep learning algorithm, specifically a deep learning autoencoder model combined with a Gaussian mixture model, to identify endotypes of hypotension based on stroke volume index, heart rate, systemic vascular resistance index, and stroke volume variation observed during episodes of hypotension. The algorithm was developed with data from 871 surgical patients who had 6962 hypotensive events and validated in two independent datasets, one including 1000 surgical patients who had 7904 hypotensive events and another including 1000 critically ill patients who had 53 821 hypotensive events. We defined hypotension as a mean arterial pressure

Published
2025

3. Comparison of differences in cohort (forwards) and case control (backwards) methodological approaches for validation of the Hypotension Prediction Index.

Author

Davies, Simon J, Sessler, Daniel I, Jian, Zhongping, Fleming, Neal W, Mythen, Monty, Maheshwari, Kamal, Veelo, Denise P, Vlaar, Alexander Pj, Settels, Jos, Scheeren, Thomas, van der Ster, Bjp, Sander, Michael, Cannesson, Maxime, and Hatib, Feras

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Anesthesiology, Clinical sciences
Abstract

BackgroundThe Hypotension Prediction Index (the index) software is a machine learning algorithm that detects physiological changes that may lead to hypotension. The original validation used a case control (backwards) analysis that has been suggested to be biased. We therefore conducted a cohort (forwards) analysis and compared this to the original validation technique.MethodsWe conducted a retrospective analysis of data from previously reported studies. All data were analysed identically with 2 different methodologies and receiver operating characteristic curves (ROC) constructed. Both backwards and forwards analyses were performed to examine differences in area under the ROC for HPI and other haemodynamic variables to predict a MAP < 65mmHg for at least 1 minute 5, 10 and 15 minutes in advance.ResultsTwo thousand and twenty-two patients were included in the analysis, yielding 4,152,124 measurements taken at 20 second intervals. The area-under-the-curve for the index predicting hypotension analysed by backward and forward methodologies respectively was 0.957 (95% CI, 0.947-0.964) vs 0.923 (95% CI, 0.912-0.933) 5 minutes in advance, 0.933 (95% CI, 0.924-0.942) vs 0.923 (95% CI, 0.911-0.933) 10 minutes in advance , and 0.929 (95% CI, 0.918-0.938) vs. 0.926 (95% CI, 0.914-0.937) 15 minutes in advance. No other variable had an area-under-the-curve > 0.7 except for MAP. Area-under-the-curve using forward analysis for MAP predicting hypotension 5, 10, and 15 minutes in advance was 0.932 (95% CI, 0.920-0.940), 0.929 (95% CI, 0.918-0.938), and 0.932 (95% CI, 0.921-0.940). The R 2 for the variation in the index due to MAP was 0.77.ConclusionUsing an updated methodology, we found the utility of the HPI index to predict future hypotensive events is high, with an area under the receiver-operating-characteristics curve similar to that of the original validation method.

Published
2024

5. Patient-centered results from a multicenter study of continuous peripheral nerve blocks and postamputation phantom and residual limb pain: secondary outcomes from a randomized, clinical trial

Author

Ilfeld, Brian M, Khatibi, Bahareh, Maheshwari, Kamal, Madison, Sarah, Esa, Wael Ali Sakr, Mariano, Edward R, Kent, Michael, Hanling, Steven, Sessler, Daniel I, Eisenach, James C, Cohen, Steven P, Mascha, Edward, Li, Shuyi, Turan, Alparslan, and Investigators, The PAINfRE

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Chronic Pain, Clinical Trials and Supportive Activities, Neurosciences, Clinical Research, Pain Research, 6.1 Pharmaceuticals, Humans, Phantom Limb, Ropivacaine, Pain, Postoperative, Peripheral Nerves, Patient-Centered Care, analgesia, CHRONIC PAIN, Anesthesia, Local, Upper Extremity, Lower Extremity, PAINfRE Investigators, Anesthesia, Local, Anesthesiology, Clinical sciences
Abstract

IntroductionWe previously reported that a 6-day continuous peripheral nerve block reduces established postamputation phantom pain. To provide patients and providers with the information to best inform treatment decisions, here we reanalyze the data and present the results in a more patient-centered format. We also provide information on patient-defined clinically relevant benefits to facilitate evaluation of available studies and guide future trial design.MethodsThe original trial enrolled participants with a limb amputation and phantom pain who were randomized to receive a 6-day continuous peripheral nerve block(s) of either ropivacaine (n=71) or saline (n=73) in a double-masked fashion. Here we calculate the percentage of each treatment group that experienced a clinically relevant improvement as defined by previous studies as well as present what the participants of our study defined as small, medium, and large analgesic improvements using the 7-point ordinal Patient Global Impression of Change scale.ResultsAmong patients who were given a 6-day ropivacaine infusion, 57% experienced at least a 2-point improvement on the 11-point numeric rating scale in their average and worst phantom pain 4 weeks postbaseline as compared with 26% (p

Published
2023

6. Best Practice Alerts Informed by Inpatient Opioid Intake to Reduce Opioid Prescribing after Surgery (PRIOR): A Cluster Randomized Multiple Crossover Trial.

Author

Rolfzen, Megan, Wick, Abraham, Mascha, Edward, Shah, Karan, Krause, Martin, Fernandez-Bustamante, Ana, Kutner, Jean, Ho, P, Sessler, Daniel, and Bartels, Karsten

Subjects
Humans, Analgesics, Opioid, Inpatients, Aftercare, Cross-Over Studies, Patient Discharge, Practice Patterns, Physicians, Morphine Derivatives, Pain, Postoperative
Abstract

BACKGROUND: Overprescription of opioids after surgery remains common. Residual and unnecessarily prescribed opioids can provide a reservoir for nonmedical use. This study therefore tested the hypothesis that a decision-support tool embedded in electronic health records guides clinicians to prescribe fewer opioids at discharge after inpatient surgery. METHODS: This study included 21,689 surgical inpatient discharges in a cluster randomized multiple crossover trial from July 2020 to June 2021 in four Colorado hospitals. Hospital-level clusters were randomized to alternating 8-week periods during which an electronic decision-support tool recommended tailored discharge opioid prescriptions based on previous inpatient opioid intake. During active alert periods, the alert was displayed to clinicians when the proposed opioid prescription exceeded recommended amounts. No alerts were displayed during inactive periods. Carryover effects were mitigated by including 4-week washout periods. The primary outcome was oral morphine milligram equivalents prescribed at discharge. Secondary outcomes included combination opioid and nonopioid prescriptions and additional opioid prescriptions until day 28 after discharge. A vigorous state-wide opioid education and awareness campaign was in place during the trial. RESULTS: The total postdischarge opioid prescription was a median [quartile 1, quartile 3] of 75 [0, 225] oral morphine milligram equivalents among 11,003 patients discharged when the alerts were active and 100 [0, 225] morphine milligram equivalents in 10,686 patients when the alerts were inactive, with an estimated ratio of geometric means of 0.95 (95% CI, 0.80 to 1.13; P = 0.586). The alert was displayed in 28% (3,074 of 11,003) of the discharges during the active alert period. There was no relationship between the alert and prescribed opioid and nonopioid combination medications or additional opioid prescriptions written after discharge. CONCLUSIONS: A decision-support tool incorporated into electronic medical records did not reduce discharge opioid prescribing for postoperative patients in the context of vigorous opioid education and awareness efforts. Opioid prescribing alerts might yet be valuable in other contexts.(Anesthesiology 2023; 139:186-96).

Published
2023

8. Smallest Clinically Meaningful Improvement in Amputation-Related Pain and Brief Pain Inventory Scores as Defined by Patient Reports of Global Improvement After Cryoneurolysis: a Retrospective Analysis of a Randomized, Controlled Clinical Trial

Author

Ilfeld, Brian M., Smith, Cameron R., Turan, Alparslan, Mariano, Edward R., Miller, Matthew E., Fisher, Rick L., Trescot, Andrea M., Cohen, Steven P., Eisenach, James C., Sessler, Daniel I., Prologo, J. David, Mascha, Edward J., Liu, Liu, Gabriel, Rodney A., Hayek, Salim M., Wadhwa, Anupama N., Beck, Gerald J., Abdullah, Baharin, Ali Sakr Esa, Wael, Altinpulluk, Ece Yamak, Bakal, Omer, Bravo, Mauro, Jiang, Qiliang, Khan, Zafeer, Maheshwari, Kamal, Mounir-Soliman, Loran, Salih, Ahmed, Hackworth, Robert J., Sigmon, Carter, Padwal, Jennifer, Gunnett, Amy M., Thaper, Akshay, and Hunt, Morgan

Published
2024
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9. Preoperative estimated glomerular filtration rate to predict cardiac events in major noncardiac surgery: a secondary analysis of two large international studies

Author

Roshanov, Pavel S., Walsh, Michael W., Garg, Amit X., Cuerden, Meaghan, Lam, Ngan N., Hildebrand, Ainslie M., Lee, Vincent W., Mrkobrada, Marko, Leslie, Kate, Chan, Matthew T.V., Borges, Flavia K., Wang, Chew Yin, Xavier, Denis, Sessler, Daniel I., Szczeklik, Wojciech, Meyhoff, Christian S., Srinathan, Sadeesh K., Sigamani, Alben, Villar, Juan Carlos, Chow, Clara K., Polanczyk, Carísi A., Patel, Ameen, Harrison, Tyrone G., Fielding-Singh, Vikram, Cata, Juan P., Parlow, Joel, de Nadal, Miriam, and Devereaux, P.J.

Published
2025
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13. A sub-study of the POISE-3 randomized trial examined effects of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of acute kidney injury

Author

Garg, Amit X., Marcucci, Maura, Cuerden, Meaghan S., Sontrop, Jessica M., Painter, Thomas W., Lomivorotov, Vladimir, Sessler, Daniel I., Chan, Matthew T.V., Borges, Flavia K., Leslie, Kate, Duceppe, Emmanuelle, Parikh, Chirag R., Roshanov, Pavel, Martínez-Zapata, María José, Wang, Chew Yin, Xavier, Denis, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V., Szczeklik, Wojciech, Schmartz, Denis, Meyhoff, Christian S., Short, Timothy G., Amir, Mohammed, Torres, David, Wittmann, Maria, Patel, Ameen, Ruetzler, Kurt, Parlow, Joel L., Jayaram, Raja, Polanczyk, Carisi A., Fleischmann, Edith, Tandon, Vikas, Astrakov, Sergey V., Conen, David, Kei Wu, William Ka, Cheong, Chao Chia, Ayad, Sabry, Kirov, Mikhail, de Nadal, Miriam, Likhvantsev, Valery V., Paniagua, Pilar, Aguado, Hector J., Ofori, Sandra N., Vincent, Jessica, Copland, Ingrid, Balasubramanian, Kumar, Biccard, Bruce M., Srinathan, Sadeesh, Ismoilov, Samandar, Wang, Michael Ke, Kurz, Andrea, Belley-Cote, Emilie P., Bhatt, Keyur, Eikelboom, John, Gross, Peter, Lamy, Andre, McGillion, Michael, McIntyre, William, Richards, Toby, Spence, Jessica, Van Helder, Thomas, Whitlock, Richard, and Devereaux, P.J.

Published
2025
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14. Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial

Author

Ilfeld, Brian M, Smith, Cameron R, Turan, Alparslan, Mariano, Edward R, Miller, Matthew E, Fisher, Rick L, Trescot, Andrea M, Cohen, Steven P, Eisenach, James C, Sessler, Daniel I, Prologo, J David, Mascha, Edward J, Liu, Liu, Gabriel, Rodney A, and Investigators, the PAINfRE

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Pain Research, Chronic Pain, Clinical Research, Clinical Trials and Supportive Activities, Neurosciences, 6.1 Pharmaceuticals, Neurological, Humans, Phantom Limb, Cold Temperature, Lidocaine, Nerve Block, Ultrasonography, Interventional, PAINfRE Investigators, Anesthesiology, Clinical sciences
Abstract

BackgroundPostamputation phantom pain is notoriously persistent with few validated treatments. Cryoneurolysis involves the application of low temperatures to reversibly ablate peripheral nerves. The authors tested the hypothesis that a single cryoneurolysis treatment would decrease phantom pain 4 months later.MethodsThe authors enrolled patients with a lower-limb amputation and established phantom pain. Each received a single-injection femoral and sciatic nerve block with lidocaine and was subsequently randomized to receive either ultrasound-guided percutaneous cryoneurolysis or sham treatment at these same locations. The primary outcome was the change in average phantom pain intensity between baseline and 4 months as measured with a numeric rating scale (0 to 10), after which an optional crossover treatment was offered. Investigators, participants, and clinical staff were masked to treatment group assignment with the exception of the treating physician performing the cryoneurolysis, who had no subsequent participant interaction.ResultsPretreatment phantom pain scores were similar in both groups, with a median [quartiles] of 5.0 [4.0, 6.0] for active treatment and 5.0 [4.0, 7.0] for sham. After 4 months, pain intensity decreased by 0.5 [-0.5, 3.0] in patients given cryoneurolysis (n = 71) versus 0 [0, 3] in patients given sham (n = 73), with an estimated difference (95% CI) of -0.1 (-1.0 to 0.7), P = 0.759. Following their statistical gatekeeping protocol, the authors did not make inferences or draw conclusions on secondary endpoints. One serious adverse event occurred after a protocol deviation in which a femoral nerve cryolesion was induced just below the inguinal ligament-instead of the sensory-only saphenous nerve-which resulted in quadriceps weakness, and possibly a fall and clavicle fracture.ConclusionsPercutaneous cryoneurolysis did not decrease chronic lower extremity phantom limb pain 4 months after treatment. However, these results were based upon the authors' specific study protocol, and since the optimal cryoneurolysis treatment parameters such as freeze duration and anatomic treatment location remain unknown, further research is warranted.Editor’s perspective

Published
2023

15. Continuous vital sign monitoring on surgical wards: The COSMOS pilot

Author

Rodriguez, Fabio, Mueller-Wirtz, Lukas, Mueller, Carolin Martina, Slife, Maeve, Mosqueda, Michael, Gatt, Richard, Nikoo, Maedeh Zokaei, Cekmecelioglu, Busra Tok, Kopac, Orkun, Singh, Sumi, Corrales Martinez, Maria J., Karki, Deeven, Medellin, Sara, Erazo, Valentina Lara, Brooker, Jack, Rössler, Julian, Mukhia, Rupashi, Pu, Xuan, Anusic, Nikola, Gulluoglu, Alper, Ekrami, Elyad, Mascha, Edward J., Li, Shuyi, Coffeng, René, Turan, Alparslan, Clemens, Amber, Perez, Christine, Beard, John W., and Sessler, Daniel I.

Published
2024
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16. Perioperative fluid management: evidence-based consensus recommendations from the international multidisciplinary PeriOperative Quality Initiative

Author

Auzinger, Georg, Chappell, Desirée, Gan, Tong J., Edwards, Mark, Fletcher, Nick, Forni, Lui G., Grocott, Michael P.W., Kunst, Gudrun, Miller, Timothy E., Morton-Bailey, Vicki, Myles, Paul S., Ostermann, Marlies, Raphael, Jacob, Saugel, Bernd, Sessler, Daniel I., Shaw, Andrew D., Zarbock, Alexander, Grocott, Michael, and Morton-Bailey, Victoria

Published
2024
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19. Temporal Trends in the Management Practices of Clinically Important Perioperative Atrial Fibrillation After Noncardiac Surgery

Author

Wang, Michael Ke, Devereaux, P.J., Marcucci, Maura, Lomivorotov, Vladimir, Sessler, Daniel I., Chan, Matthew T.V., Borges, Flavia K., Ofori, Sandra N., Paniagua, Pilar, Douketis, James D., Sigamani, Alben, Parlow, Joel L., Wang, Chew Y., Villar, Juan Carlos, Srinathan, Sadeesh K., Szczeklik, Wojciech, Martínez-Zapata, María José, Malaga, German, Sivakumaran, Soori, McIntyre, William F., Rodríguez Funes, María-Virginia, Cruz, Patricia, Alvarez-Garcia, Jesús, Greiss, Isabelle, Popova, Ekaterine, Hemels, Martin E., Brandes, Axel, Chow, Clara K., Barnawal, Satish Prasad, Healey, Jeff S., and Conen, David

Published
2024
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24. The relative merits of using a high-sensitivity cardiac Troponin T assay compared to a nonhigh-sensitivity troponin T assay after noncardiac surgery

Author

Borges, Flavia K., Sessler, Daniel I., Tiboni, Maria, Patel, Ameen, LeManach, Yannick, Heels-Ansdell, Diane, Srinathan, Sadeesh, Wang, Chew Yin, Chow, Clara, Duceppe, Emmanuelle, Kavsak, Peter, Ofori, Sandra N., Pettit, Shirley, Berwanger, Otavio, Kurz, Andrea, Turan, Alparslan, Tonelli, Ana Claudia, and Devereaux, PJ

Published
2024
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25. Effect of colchicine on perioperative atrial fibrillation and myocardial injury after non-cardiac surgery in patients undergoing major thoracic surgery (COP-AF): an international randomised trial

Author

Conen, David, Devereaux, PJ, Vincent, Jessica, Wang, Michael Ke, Wells, Jennifer R., Healey, Jeff S., Landoni, Giovanni, McIntyre, William F., Popova, Ekaterine, Sessler, Daniel I., Srinathan, Sadeesh K., Amir, Mohammed, Bangdiwala, Shrikant I., Bossard, Matthias, Chan, Matthew TV, Eikelboom, John W., Fleischmann, Edith, Jolly, Sanjit, Montes, Felix Ramón, Reimer, Cara, Schmartz, Denis, Wang, Chew Yin, Ofori, Sandra N., Blum, Steffen, Alvarez-Garcia, Jesus, Lo Bianco, Giuliana, Traquair, Hugh, Guerrero-Pinedo, Fernando Andres, Oleynick, Christopher, Meyre, Pascal B., Méndez-Zurita, Francisco, Chiarella-Redfern, Helene, Marcucci, Maura, Donati, Francesco, Gonzalez-Osuna, Aranzazu, Minervini, Fabrizio, Moreno Weidmann, Zoraida, Guerra-Ramos, Jose M., Dion, Gabriel, Ramos-Pachón, Anna, Borges, Flavia K., de Sa Boasquevisque, Danielle, Mosconi, Maria Giulia, Amarenco, Pierre, Mitchell, L. Brent, Wyse, George, Cheng, Davy, McAlister, Finlay A., Wells, George A., Baskaran, Geethan, Burns, Andrew T., Gennaccaro, Julia, Howe, Rosemary, Mastrangelo, Louise, Pettit, Shirley, Popovic, Michelle, Shahbaz, Subana, Tosh, Makayla, Zucchetto, Simona J., Heenan, Laura, Lee, Shun Fu, Li, Zhuoru, Xu, Lizhen, Kabon, Barbara, Hoetzenecker, Konrad, Schweiger, Thomas, Reiterer, Christian, Zotti, Oliver, Bsuchner, Paul, Hochreiter, Beatrix, Taschner, Alexander, Adamowitsch, Nikolas, Horvath, Katharina, Hantáková, Nicole, Bidgoli, Javad, Huybrechts, Isabelle, Cappeliez, Serge, Neary, John D., Shargall, Yaron, Tandon, Vikas, Finley, Christian, Agzarian, John, Hanna, Waël, Abdulrahman, Muammar, Lawrence, Kelly, Gregus, Krysten, Quraishi, Faraaz, Wikkerink, Spencer, Wallace, Christine, Prine, Merissa, Gregus, Emily, Hare, Jacqueline, Lombardo, Kristen, Fezia, Behashta, Columbus, Teresa, Rushton, Jacob, DuMerton, Deborah, Reid, Ken, Parlow, Joel, Chung, Wiley, Karizhenskaia, Maria, Malik, Aftab, Tanzola, Rob, Giles, Andrew, McLean, Sean R., McGuire, Anna, Lohser, Jens, Lim, Shirley, Grey, Rebecca, Yee, John, Grant, Kyle, Lee, Alex L., Choi, James J., Dewar, Leith R., Durkin, Christopher, Schisler, Travis, Hecht, Patrick, Hughes, Bevan, Kidane, Biniam, Liu, Richard, Tan, Lawrence, Gowing, Stephen, Buduhan, Gordon, Enns, Stephanie, Poole, Emma, Graham, Kristin, Dubik, Niina, Chin, Alex, Maziak, Donna E., Seely, Andrew JE, Gilbert, Sebastien, Villeneuve, P. James, Sundaresan, Sudhir, Gingrich, Molly, Fazekas, Anna, Bucciero, Kirby, Malthaner, Richard A., Lewis, Deb, Fortin, Dalilah, Qiabi, Mehdi, Nayak, Rahul, Plourde, Madelaine Marie, Haider, Tehmina, Murphy, Rowan, Sellers, Daniel, Donahoe, Laura, Lefebvre, Marco, Lanthier, Luc, Ko, Michael Augustine, Parente, David, Cheung, Victoria, Schieman, Colin, Bessissow, Amal, Wong, Randolph HL, Joynt, Gavin M., Lam, Carmen KM, Lau, Rainbow WH, Wan, Innes YP, Underwood, Malcolm J., Wu, William KK, Wong, Wai Tat, Choi, Gordon YS, Lee, Eva, Hui, Ka Yan, Fung, Beaker, Chan, Chee Sam, Ng, Fung Kei, Thung, Kin Hoi, Gutiérrez-Soriano, Laura, Castañeda, Laura Carmenza, Téllez, Luis Jaime, Ortiz-Ramirez, Lina Marcela, Baiardo-Redaelli, Martina, Belletti, Alessandro, Dieci, Elisa, Monaco, Fabrizio, Muriana, Piergiorgio, Nakhnoukh, Cristina, Novellis, Pierluigi, Turi, Stefano, Viscardi, Stefano, Veronesi, Giulia, Voltolini, Luca, Bongiolatti, Stefano, Salvicchi, Alberto, Gatteschi, Lavinia, Indino, Rossella, Tombelli, Simone, Ravasin, Alice, Salimbene, Ottavia, Rosboch, Giulio Luca, Balzani, Eleonora, Ceraolo, Edoardo, Neitzert, Luca, Brazzi, Luca, Londero, Francesco, Grossi, William, Massullo, Domenico, Fiorelli, Silvia, Margaritora, Stefano, Hashim, Shahrul Amry, Krishnasamy, Sivakumar, See, Woan Shiang, Nawaz, Mohammed Asghar, Bilal, Haris, Trujillo Reyes, Juan Carlos, Martínez-Téllez, Elisabeth, Belda Sanchis, Josep, Planas Canovas, Georgina, Libreros Niño, Alejandra, Parera Ruiz, Ana, Cladellas Gutierrez, Esther, Guarino, Mauro, Urrutia Cuchi, Gerard, Argilaga Nogues, Marta, Rovira Juan, Anna, Medina-Aedo, Melixa, Turró Castillejo, Mª Asunción, Gil Sanchez, Josep Mª, Araúz-Sarmiento, Ibell, Herranz Perez, Gracia, Chavarria Murillo, Stephania, Garcia-Osuna, Alvaro, Rodriguez-Arias, Ainhoa, Berga Garrote, Nuria, Martín Grande, Ascension, Parise Roux, Diego, Gajate Martín, Luis, De Pablo Pajares, Angélica, Candela Toha, Angel Manuel, Moreno Mata, Nicolás, Muñoz Molina, Gema, Caballero Silva, Usue, Cabañero, Alberto, Fra Fernandez, Sara, Cavestany García-Matres, Cristina, Simón, Luisa, Montenegro, Cristina, Pozo, Sergio, Gonzàlez-Tallada, Anna, González Suarez, Susana, Ribas Ball, Montserrat, De Nadal Clanchet, Miriam, Pérez Vélez, Javier, Cruz, Patrícia, Sánchez-Pedrosa, Guillermo, Duque, Patricia, González, Guillermo, Huerta, Luis, Rodríguez, Laura, Garutti, Ignacio, Ruiz-Villa, Laura, Martí-Ejarque, Maria del Mar, Gili-Bueno, Mireia, Maddio Vieyra, Ricardo Matias, Fibla, Juan J., Durán, Núria, de Temple Pla, Marina, Rodríguez-Fuster, Alberto, Bermejo-Martínez, Silvia, Carramiñana, Albert, Opitz, Isabelle, Etienne, Harry, Cata, Juan P., Guerra-Londono, Juan Jose, Rajaram, Ravi, Corrales, German, Vaporciyan, Ara, Mehran, Reza, Sepesi, Boris, Walsh, Garrett, Rice, David, Cukierman, Daniel S., Swisher, Stephen, Marchant, Bryan E., Harris, Lynne C., Cusson, Bruce D., Miller, Scott A., Ayad, Sabry, Araujo, Jorge, Marquez-Roa, Leonardo, Hofstra, Richard L., Wudel, Jr., Leonard J., Minear, Steven C., Teixeira, Camila, Pimentel, Mario, Popoff, Andrew M., Marsack, Kelly, Meehan, Sarah, Chen, Tzonghuei H., Essandoh, Michael, Poppers, Jeremy S., Ke Wang, Michael, Chan, Matthew T V, Cata, Juan P, McLean, Sean R, Srinathan, Sadeesh K, Reyes, Juan Carlos Trujillo, Grande, Ascension Martín, Tallada, Anna Gonzalez, Sessler, Daniel I, Maziak, Donna E, McIntyre, William F, Wong, Randolph H L, McGuire, Anna L, Roux, Diego Parise, Wells, Jennifer R, Ofori, Sandra N, Eikelboom, John W, Jolly, Sanjit S, Healey, Jeff S, and Devereaux, P J

Published
2023
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30. Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial

Author

Funcke, Sandra, Schmidt, Götz, Bergholz, Alina, Argente Navarro, Pilar, Azparren Cabezón, Gonzalo, Barbero-Espinosa, Silvia, Diaz-Cambronero, Oscar, Edinger, Fabian, García-Gregorio, Nuria, Habicher, Marit, Klinkmann, Gerd, Koch, Christian, Kröker, Alina, Mencke, Thomas, Moral García, Victoria, Zitzmann, Amelie, Lezius, Susanne, Pepić, Amra, Sessler, Daniel I., Sander, Michael, Haas, Sebastian A., Reuter, Daniel A., and Saugel, Bernd

Published
2024
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33. Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study

Author

McGillion, Michael H., Borges, Flavia K., Conen, David, Sessler, Daniel I., Coleman, Brenda L., Marcucci, Maura, Ouellette, Carley, Bird, Marissa, Whitmore, Carly, Henry, Shaunattonie, Ofori, Sandra, Pettit, Shirley M., Bedini, Deborah M., Gauthier, Leslie P., Lounsbury, Jennifer, Carter, Nancy M., Tandon, Vikas, Patel, Ameen, Cafaro, Teresa, Simunovic, Marko R., Harlock, John A., Heels-Ansdell, Diane, Elias, Fadi, Rapanos, Theodore, Forbes, Shawn, Peter, Elizabeth, Watt-Watson, Judy, Metcalfe, Kelly, Carroll, Sandra L., and Devereaux, Philip J.

Published
2024
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37. Processing speed test and 30-day readmission in elderly non-cardiac surgery patients- A retrospective study

Author

Maheshwari, Kamal, Yalcin, Esra Kutlu, Wang, Dong, Mascha, Edward J., Rosenfeldt, Anson, Alberts, Jay L., Turan, Alparslan, Sessler, Daniel I., and Cummings III, Kenneth C.

Subjects
Psychological aspects, Physiological aspects, Usage, Elderly patients -- Physiological aspects -- Psychological aspects, Surgery -- Physiological aspects, Medical research, Cognitive tests -- Usage, Cognition -- Testing, Medicine, Experimental, Aged patients -- Physiological aspects -- Psychological aspects
Abstract

Author(s): Kamal Maheshwari (corresponding author) [1,2]; Esra Kutlu Yalcin [2]; Dong Wang [2,3]; Edward J. Mascha [2,3]; Anson Rosenfeldt [4]; Jay L. Alberts [4]; Alparslan Turan [1,2]; Daniel I. Sessler [...], Background and Aims: Preoperative cognitive function screening can help identify high-risk patients, but resource-intensive testing limits its widespread use. A novel self-administered tablet computer-based Processing Speed Test (PST) was used to assess cognitive "executive" function in non-cardiac surgery patients, but the relationship between preoperative test scores and postoperative outcomes is unclear. The primary outcome was a composite of 30-day readmission/death. The secondary outcome was a collapsed composite of discharge to a long-term care facility/death. Exploratory outcomes were 1) time to discharge alive, 2) 1-year mortality and 3) a collapsed composite of postoperative complications. Methods: This retrospective study, after approval, was conducted in elective non-cardiac surgery patients ≥65 years old. We assessed the relationship between processing speed test scores and primary/secondary outcomes using multivariable logistic regression, adjusting for potential confounding variables. Results: Overall 1568 patients completed the PST, and the mean ± standard deviation test score was 33 ± 10. The higher PST score is associated with better executive function. A 10-unit increase in the test score was associated with an estimated 19 lower 30-day readmission/death odds, with an odds ratio (OR) and 95 confidence interval (CI) of 0.81 (0.68, 0.96) (P = 0.015). Similarly, 10-unit increase in test score was associated with an estimated 26 lower odds of long-term care need/death, with OR (95 CI) of 0.74 (0.61, 0.91) (P = 0.004). We also found statistically significant associations between the test scores and time to discharge alive and to 1-year mortality, however, not with a composite of postoperative complications. Conclusion: Elderly non-cardiac surgery patients with better PST scores were less likely to be readmitted, need long-term care after discharge or die within 30 days. Preoperative assessment of cognitive function using a simple self-administered test is feasible and may guide perioperative care. Keywords: Cognition, processing speed test, readmission, non-cardiac surgery

Published
2023
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38. Design of Clinical Trials Evaluating Sedation in Critically Ill Adults Undergoing Mechanical Ventilation: Recommendations From Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research (SCEPTER) Recommendation III

Author

Ward, Denham S, Absalom, Anthony R, Aitken, Leanne M, Balas, Michele C, Brown, David L, Burry, Lisa, Colantuoni, Elizabeth, Coursin, Douglas, Devlin, John W, Dexter, Franklin, Dworkin, Robert H, Egan, Talmage D, Elliott, Doug, Egerod, Ingrid, Flood, Pamela, Fraser, Gilles L, Girard, Timothy D, Gozal, David, Hopkins, Ramona O, Kress, John, Maze, Mervyn, Needham, Dale M, Pandharipande, Pratik, Riker, Richard, Sessler, Daniel I, Shafer, Steven L, Shehabi, Yahya, Spies, Claudia, Sun, Lena S, Tung, Avery, and Urman, Richard D

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Prevention, Clinical Trials and Supportive Activities, Clinical Research, Patient Safety, Generic health relevance, Quality Education, Congresses as Topic, Consensus, Delphi Technique, District of Columbia, Humans, Hypnotics and Sedatives, Respiration, Artificial, Time Factors, clinical trial, intensive care, outcome assessments, research methodology, sedation, Nursing, Public Health and Health Services, Emergency & Critical Care Medicine, Clinical sciences
Abstract

ObjectivesClinical trials evaluating the safety and effectiveness of sedative medication use in critically ill adults undergoing mechanical ventilation differ considerably in their methodological approach. This heterogeneity impedes the ability to compare results across studies. The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research Recommendations convened a meeting of multidisciplinary experts to develop recommendations for key methodologic elements of sedation trials in the ICU to help guide academic and industry clinical investigators.DesignA 2-day in-person meeting was held in Washington, DC, on March 28-29, 2019, followed by a three-round, online modified Delphi consensus process.ParticipantsThirty-six participants from academia, industry, and the Food and Drug Administration with expertise in relevant content areas, including two former ICU patients attended the in-person meeting, and the majority completed an online follow-up survey and participated in the modified Delphi process.Measurements and main resultsThe final recommendations were iteratively refined based on the survey results, participants' reactions to those results, summaries written by panel moderators, and a review of the meeting transcripts made from audio recordings. Fifteen recommendations were developed for study design and conduct, subject enrollment, outcomes, and measurement instruments. Consensus recommendations included obtaining input from ICU survivors and/or their families, ensuring adequate training for personnel using validated instruments for assessments of sedation, pain, and delirium in the ICU environment, and the need for methodological standardization.ConclusionsThese recommendations are intended to assist researchers in the design, conduct, selection of endpoints, and reporting of clinical trials involving sedative medications and/or sedation protocols for adult ICU patients who require mechanical ventilation. These recommendations should be viewed as a starting point to improve clinical trials and help reduce methodological heterogeneity in future clinical trials.

Published
2021

40. Assisted Fluid Management Software Guidance for Intraoperative Fluid Administration

Author

Maheshwari, Kamal, Malhotra, Gaurav, Bao, Xiaodong, Lahsaei, Peiman, Hand, William R, Fleming, Neal W, Ramsingh, Davinder, Treggiari, Miriam M, Sessler, Daniel I, and Miller, Timothy E

Subjects
Bioengineering, Clinical Research, Aged, Cohort Studies, Female, Fluid Therapy, Humans, Intraoperative Care, Male, Middle Aged, Therapy, Computer-Assisted, Assisted Fluid Management Study Team, Clinical Sciences, Anesthesiology
Abstract

BackgroundExcessive or inadequate fluid administration causes complications, but despite this, fluid administration during noncardiac surgery is highly variable. Goal-directed management helps optimize the amount and timing of fluid administration; however, implementation is difficult because algorithms are complex. The authors therefore tested the performance of the Acumen Assisted Fluid Management software (Edwards Lifesciences, USA), which is designed to guide optimal intravenous fluid administration during surgery.MethodsIn this multicenter, prospective, single-arm cohort evaluation, the authors enrolled 330 adults scheduled for moderate- to high-risk noncardiac surgery that required arterial catheter insertion and mechanical ventilation. Clinicians chose a fluid strategy based on a desired 10%, 15%, or 20% increase in stroke volume (SV) in response to a fluid bolus. Dedicated fluid management software prompted "test" or "recommended" boluses, and clinicians were free to initiate a "user" bolus of 100 to 500 ml of crystalloid or colloid. Clinicians were free to accept or decline the software prompts. The authors primarily compared the fraction of software-recommended boluses that produced suitable increases in SV to a 30% reference rate. On an exploratory basis, we compared responses to software-recommended and clinician-initiated boluses.ResultsFour hundred twenty-four of 479 (89%) software-recommended fluid boluses and 508 of 592 (86%) clinician-initiated fluid boluses were analyzed per protocol. Of those, 66% (95% CI, 62 to 70%) of delivered fluid boluses recommended by the software resulted in desired increases in SV, compared with the 30% reference rate, whereas only 41% (95% CI, 38 to 44%) of clinician-initiated boluses did (P < 0.0001). The mean ± SD increase in SV after boluses recommended by the software was 14.2 ± 13.9% versus 8.3 ± 12.1% (P < 0.0001) for those initiated by clinicians.ConclusionsFluid boluses recommended by the software resulted in desired SV increases more often, and with greater absolute SV increase, than clinician-initiated boluses. Automated assessment of fluid responsiveness may help clinicians optimize intraoperative fluid management during noncardiac surgery.Editor’s perspective

Published
2021

44. Long-term Outcomes with Spinal versus General Anesthesia for Hip Fracture Surgery: A Randomized Trial

Author

Vail, Emily A., Feng, Rui, Sieber, Frederick, Carson, Jeffrey L., Ellenberg, Susan S., Magaziner, Jay, Dillane, Derek, Marcantonio, Edward R., Sessler, Daniel I., Ayad, Sabry, Stone, Trevor, Papp, Steven, Donegan, Derek, Mehta, Samir, Schwenk, Eric S., Marshall, Mitchell, Jaffe, J. Douglas, Luke, Charles, Sharma, Balram, Azim, Syed, Hymes, Robert, Chin, Ki-Jinn, Sheppard, Richard, Perlman, Barry, Sappenfield, Joshua, Hauck, Ellen, Tierney, Ann, Horan, Annamarie D., Neuman, Mark D., Looke, Thomas, Bent, Sandra, Franco-Mora, Ariana, Hedrick, Pamela, Newbern, Matthew, Tadros, Rafik, Pealer, Karen, Vlassakov, Kamen, Buckley, Carolyn, Gavin, Lauren, Gorbatov, Svetlana, Gosnell, James, Steen, Talora, Vafai, Avery, Zeballos, Jose, Hruslinski, Jennifer, Cardenas, Louis, Berry, Ashley, Getchell, John, Quercetti, Nicholas, Hassan, Manal, Bajracharya, Gauasan, Billow, Damien, Bloomfield, Michael, Cuko, Evis, Elyaderani, Mehrun K., Hampton, Robert, Honar, Hooman, Khoshknabi, Dilara, Kim, Daniel, Krahe, David, Lew, Michael M., Maheshwer, Conjeevram B., Niazi, Azfar, Saha, Partha, Salih, Ahmed, de Swart, Robert J., Volio, Andrew, Bolkus, Kelly, DeAngelis, Matthew, Dodson, Gregory, Gerritsen, Jeffrey, McEniry, Brian, Mitrev, Ludmil, Kwofie, M. Kwesi, Belliveau, Anne, Bonazza, Flynn, Lloyd, Vera, Panek, Izabela, Dabiri, Jared, Chavez, Chris, Craig, Jason, Davidson, Todd, Dietrichs, Chad, Fleetwood, Cheryl, Foley, Mike, Getto, Chris, Hailes, Susie, Hermes, Sarah, Hooper, Andy, Koener, Greg, Kohls, Kate, Law, Leslie, Lipp, Adam, Losey, Allison, Nelson, William, Nieto, Mario, Rogers, Pam, Rutman, Steve, Scales, Garrett, Sebastian, Barbara, Stanciu, Tom, Lobel, Gregg, Giampiccolo, Michelle, Herman, Dara, Kaufman, Margit, Murphy, Bryan, Pau, Clara, Puzio, Thomas, Veselsky, Marlene, Apostle, Kelly, Boyer, Dory, Chen Fan, Brenda, Lee, Susan, Lemke, Mike, Merchant, Richard, Moola, Farhad, Payne, Kyrsten, Perey, Bertrand, Viskontas, Darius, Poler, Mark, D’Antonio, Patricia, O’Neill, Greg, Abdullah, Amer, Fish-Fuhrmann, Jamie, Giska, Mark, Fidkowski, Christina, Guthrie, Stuart Trent, Hakeos, William, Hayes, Lillian, Hoegler, Joseph, Nowak, Katherine, Beck, Jeffery, Cuff, Jaslynn, Gaski, Greg, Haaser, Sharon, Holzman, Michael, Malekzadeh, A. Stephen, Ramsey, Lolita, Schulman, Jeff, Schwartzbach, Cary, Azefor, Tangwan, Davani, Arman, Jaberi, Mahmood, Masear, Courtney, Haider, Syed Basit, Chungu, Carolyn, Ebrahimi, Ali, Fikry, Karim, Marcantonio, Andrew, Shelvan, Anitha, Sanders, David, Clarke, Collin, Lawendy, Abdel, Schwartz, Gary, Garg, Mohit, Kim, Joseph, Caruci, Juan, Commeh, Ekow, Cuevas, Randy, Cuff, Germaine, Franco, Lola, Furgiuele, David, Giuca, Matthew, Allman, Melissa, Barzideh, Omid, Cossaro, James, D’Arduini, Armando, Farhi, Anita, Gould, Jason, Kafel, John, Patel, Anuj, Peller, Abraham, Reshef, Hadas, Safur, Mohammed, Toscano, Fiore, Tedore, Tiffany, Akerman, Michael, Brumberger, Eric, Clark, Sunday, Friedlander, Rachel, Jegarl, Anita, Lane, Joseph, Lyden, John P., Mehta, Nili, Murrell, Matthew T., Painter, Nathan, Ricci, William, Sbrollini, Kaitlyn, Sharma, Rahul, Steel, Peter A.D., Steinkamp, Michele, Weinberg, Roniel, Stephenson Wellman, David, Nader, Antoun, Fitzgerald, Paul, Ritz, Michaela, Bryson, Greg, Craig, Alexandra, Farhat, Cassandra, Gammon, Braden, Gofton, Wade, Harris, Nicole, Lalonde, Karl, Liew, Allan, Meulenkamp, Bradley, Sonnenburg, Kendra, Wai, Eugene, Wilkin, Geoffrey, Troxell, Karen, Alderfer, Mary Ellen, Brannen, Jason, Cupitt, Christopher, Gerhart, Stacy, McLin, Renee, Sheidy, Julie, Yurick, Katherine, Chen, Fei, Dragert, Karen, Kiss, Geza, Malveaux, Halina, McCloskey, Deborah, Mellender, Scott, Mungekar, Sagar S., Noveck, Helaine, Sagebien, Carlos, Biby, Luat, McKelvy, Gail, Richards, Anna, Abola, Ramon, Ayala, Brittney, Halper, Darcy, Mavarez, Ana, Rizwan, Sabeen, Choi, Stephen, Awad, Imad, Flynn, Brendan, Henry, Patrick, Jenkinson, Richard, Kaustov, Lilia, Lappin, Elizabeth, McHardy, Paul, Singh, Amara, Donnelly, Joanne, Gonzalez, Meera, Haydel, Christopher, Livelsberger, Jon, Pazionis, Theresa, Slattery, Bridget, Vazquez-Trejo, Maritza, Baratta, Jaime, Cirullo, Michael, Deiling, Brittany, Deschamps, Laura, Glick, Michael, Katz, Daniel, Krieg, James, Lessin, Jennifer, Mojica, Jeffrey, Torjman, Marc, Jin, Rongyu, Salpeter, Mary Jane, Powell, Mark, Simmons, Jeffrey, Lawson, Prentiss, Kukreja, Promil, Graves, Shanna, Sturdivant, Adam, Bryant, Ayesha, Crump, Sandra Joyce, Verrier, Michelle, Green, James, Menon, Matthew, Applegate, Richard, Arias, Ana, Pineiro, Natasha, Uppington, Jeffrey, Wolinsky, Phillip, Gunnett, Amy, Hagen, Jennifer, Harris, Sara, Hollen, Kevin, Holloway, Brian, Horodyski, Mary Beth, Pogue, Trevor, Ramani, Ramachandran, Smith, Cameron, Woods, Anna, Warrick, Matthew, Flynn, Kelly, Mongan, Paul, Ranganath, Yatish, Fernholz, Sean, Ingersoll-Weng, Esperanza, Marian, Anil, Seering, Melinda, Sibenaller, Zita, Stout, Lori, Wagner, Allison, Walter, Alicia, Wong, Cynthia, Orwig, Denise, Goud, Maithri, Helker, Chris, Mezenghie, Lydia, Montgomery, Brittany, Preston, Peter, Schwartz, J. Sanford, Weber, Ramona, Fleisher, Lee A., Mehta, Samir, Stephens-Shields, Alisa J., Dinh, Cassandra, Schwartz, Aron, Chelly, Jacques E., Goel, Shiv, Goncz, Wende, Kawabe, Touichi, Khetarpal, Sharad, Monroe, Amy, Shick, Vladislav, Breidenstein, Max, Dominick, Timothy, Friend, Alexander, Mathews, Donald, Lennertz, Richard, Sanders, Robert, Akere, Helen, Balweg, Tyler, Bo, Amber, Doro, Christopher, Goodspeed, David, Lang, Gerald, Parker, Maggie, Rettammel, Amy, Roth, Mary, White, Marissa, Whiting, Paul, Allen, Brian F.S., Baker, Tracie, Craven, Debra, McEvoy, Matt, Turnbo, Teresa, Kates, Stephen, Morgan, Melanie, Willoughby, Teresa, Weigel, Wade, Auyong, David, Fox, Ellie, Welsh, Tina, Cusson, Bruce, Dobson, Sean, Edwards, Christopher, Harris, Lynette, Henshaw, Daryl, Johnson, Kathleen, McKinney, Glen, Miller, Scott, Reynolds, Jon, Segal, B. Scott, Turner, Jimmy, VanEenenaam, David, Weller, Robert, Lei, Jineli, Treggiari, Miriam, Akhtar, Shamsuddin, Blessing, Marcelle, Johnson, Chanel, Kampp, Michael, Kunze, Kimberly, OʼConnor, Mary, Gaskins, Lakisha J., Looke, Thomas, Tadros, Rafik, Vlassakov, Kamen, Cardenas, Louis, Hassan, Manal, Bolkus, Kelly, Mitrev, Ludmil, Kwofie, M. Kwesi, Dabiri, Jared, Lobel, Gregg, Poler, Mark, Giska, Mark, Sanders, David, Schwartz, Gary, Giuca, Matthew, Tedore, Tiffany, Nader, Antoun, Papp, Stephen, Bryson, Greg, Troxell, Karen, Kiss, Geza, Choi, Stephen, Powell, Mark, Applegate, Richard, Warrick, Matthew, Ranganath, Yatish, Elkassabany, Nabil, Chelly, Jacques E., Hoeft, Mark A., Lennertz, Richard, Sanders, Robert, Allen, Brian F.S., Kates, Stephen, Weigel, Wade, Li, Jinlei, Wijeysundera, Duminda N., Kheterpal, Sachin, Moore, Reneé H., Smith, Alexander K., Tosi, Laura L., Elkassabany, Nabil, Looke, Thomas, Menio, Diane, Mehta, Samir, Fleisher, Lee, Menio, Diane, Hruslinski, Jennifer, Ramsey, Lolita, Gaskins, Lakisha J., Langlois, Christine, Gaskins, Lakisha J., Mezenghie, Lydia, Montgomery, Brittany, Oduwole, Samuel, and Rose, Thomas

Published
2024
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46. Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Pain: A Randomized, Sham-controlled Pilot Study

Author

Ilfeld, Brian M, Plunkett, Anthony, Vijjeswarapu, Alice M, Hackworth, Robert, Dhanjal, Sandeep, Turan, Alparslan, Cohen, Steven P, Eisenach, James C, Griffith, Scott, Hanling, Steven, Sessler, Daniel I, Mascha, Edward J, Yang, Dongsheng, Boggs, Joseph W, Wongsarnpigoon, Amorn, and Gelfand, Harold

Subjects
Drug Abuse (NIDA only), Neurosciences, Clinical Research, Clinical Trials and Supportive Activities, Chronic Pain, Substance Misuse, Pain Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Feasibility Studies, Female, Humans, Implantable Neurostimulators, Male, Middle Aged, Pain, Postoperative, Peripheral Nerves, Pilot Projects, Transcutaneous Electric Nerve Stimulation, Treatment Outcome, PAINfRE Investigators, Clinical Sciences, Anesthesiology
Abstract

BackgroundPercutaneous peripheral nerve stimulation is an analgesic technique involving the percutaneous implantation of a lead followed by the delivery of electric current using an external pulse generator. Percutaneous peripheral nerve stimulation has been used extensively for chronic pain, but only uncontrolled series have been published for acute postoperative pain. The current multicenter study was undertaken to (1) determine the feasibility and optimize the protocol for a subsequent clinical trial and (2) estimate the treatment effect of percutaneous peripheral nerve stimulation on postoperative pain and opioid consumption.MethodsPreoperatively, an electrical lead was percutaneously implanted to target the sciatic nerve for major foot/ankle surgery (e.g., hallux valgus correction), the femoral nerve for anterior cruciate ligament reconstruction, or the brachial plexus for rotator cuff repair, followed by a single injection of long-acting local anesthetic along the same nerve/plexus. Postoperatively, participants were randomized to 14 days of either electrical stimulation (n = 32) or sham stimulation (n = 34) using an external pulse generator in a double-masked fashion. The dual primary treatment effect outcome measures were (1) cumulative opioid consumption (in oral morphine equivalents) and (2) mean values of the "average" daily pain scores measured on the 0 to 10 Numeric Rating Scale within the first 7 postoperative days.ResultsDuring the first 7 postoperative days, opioid consumption in participants given active stimulation was a median (interquartile range) of 5 mg (0 to 30) versus 48 mg (25 to 90) in patients given sham treatment (ratio of geometric means, 0.20 [97.5% CI, 0.07 to 0.57]; P < 0.001). During this same period, the average pain intensity in patients given active stimulation was a mean ± SD of 1.1 ± 1.1 versus 3.1 ± 1.7 in those given sham (difference, -1.8 [97.5% CI, -2.6 to -0.9]; P < 0.001).ConclusionsPercutaneous peripheral nerve stimulation reduced pain scores and opioid requirements free of systemic side effects during at least the initial week after ambulatory orthopedic surgery.Editor’s perspective

Published
2021

47. Ambulatory continuous peripheral nerve blocks to treat postamputation phantom limb pain: a multicenter, randomized, quadruple-masked, placebo-controlled clinical trial

Author

Ilfeld, Brian M, Khatibi, Bahareh, Maheshwari, Kamal, Madison, Sarah J, Esa, Wael Ali Sakr, Mariano, Edward R, Kent, Michael L, Hanling, Steven, Sessler, Daniel I, Eisenach, James C, Cohen, Steven P, Mascha, Edward J, Ma, Chao, Padwal, Jennifer A, and Turan, Alparslan

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Chronic Pain, Clinical Trials and Supportive Activities, Pain Research, Peripheral Neuropathy, Neurosciences, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Neurological, Anesthetics, Local, Humans, Nerve Block, Pain, Postoperative, Peripheral Nerves, Phantom Limb, Ropivacaine, Continuous peripheral nerve blocks, Perineural local anesthetic infusion, Ambulatory analgesia, Chronic pain, PAINfRE Investigators, Medical and Health Sciences, Psychology and Cognitive Sciences, Anesthesiology, Biomedical and clinical sciences, Health sciences, Psychology
Abstract

Phantom limb pain is thought to be sustained by reentrant neural pathways, which provoke dysfunctional reorganization in the somatosensory cortex. We hypothesized that disrupting reentrant pathways with a 6-day-long continuous peripheral nerve block reduces phantom pain 4 weeks after treatment. We enrolled patients who had an upper- or lower-limb amputation and established phantom pain. Each was randomized to receive a 6-day perineural infusion of either ropivacaine or normal saline. The primary outcome was the average phantom pain severity as measured with a Numeric Rating Scale (0-10) at 4 weeks, after which an optional crossover treatment was offered within the following 0 to 12 weeks. Pretreatment pain scores were similar in both groups, with a median (interquartile range) of 5.0 (4.0, 7.0) for each. After 4 weeks, average phantom limb pain intensity was a mean (SD) of 3.0 (2.9) in patients given local anesthetic vs 4.5 (2.6) in those given placebo (difference [95% confidence interval] 1.3 [0.4, 2.2], P = 0.003). Patients given local anesthetic had improved global impression of change and less pain-induced physical and emotional dysfunction, but did not differ on depression scores. For subjects who received only the first infusion (no self-selected crossover), the median decrease in phantom limb pain at 6 months for treated subjects was 3.0 (0, 5.0) vs 1.5 (0, 5.0) for the placebo group; there seemed to be little residual benefit at 12 months. We conclude that a 6-day continuous peripheral nerve block reduces phantom limb pain as well as physical and emotional dysfunction for at least 1 month.

Published
2021

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