1. Paravertebral vs. Epidural Analgesia for Liver Surgery (PEALS): Protocol for a randomized controlled pilot study
- Author
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Glenio B. Mizubuti, Anthony M.-H. Ho, Deborah DuMerton, Rachel Phelan, Wilma M. Hopman, Camilyn Cheng, Jessica Xiong, Jessica Shelley, Elorm Vowotor, Sulaiman Nanji, Diederick Jalink, and Lais Helena Navarro e Lima
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General Immunology and Microbiology ,General Medicine ,General Pharmacology, Toxicology and Pharmaceutics ,General Biochemistry, Genetics and Molecular Biology - Abstract
Background: Perioperative thoracic epidural analgesia (TEA) is commonly used in hepatectomy patients since it is opioid-sparing and reduces cardiorespiratory complications. However, TEA has a high failure rate and is associated with potentially devastating complications (particularly spinal haematoma) and the risk is likely increased with hepatectomy. Thus, some centres favour systemic opioid-based modalities which, in turn, are associated with inferior analgesia and well-known risks/side-effects. Hence, alternative analgesic methods are desirable. Paravertebral block (PVB) has been used in liver resection with advantages including hemodynamic stability, low failure rates, and low risk of spinal haematoma. Our purpose is to conduct a blinded, pilot RCT with hepatectomy patients randomised to receive TEA or PVB for perioperative analgesia. Our hypothesis is that opioid consumption, time to first analgesic request, and pain scores will be comparable between groups, but PVB patients will require fewer perioperative vasopressors/blood products, and have fewer adverse events and a shorter hospital stay. Methods: With ethics approval, this non-inferiority, pilot RCT with a convenience sample of 50 hepatectomy patients will examine whether PVB imparts analgesia comparable to TEA but with fewer adverse effects. Primary outcomes are surrogates of analgesia for 72 h postoperatively (i.e., opioid consumption, time to first analgesic request and pain scores at rest and with coughing); Secondary outcomes are blood products/fluids administered; side effects/complications until 72 h postoperatively; length of hospital stay. The results will be used to plan a large multicentre trial comparing TEA vs. PVB in hepatectomy patients. This study has a high potential to positively impact the quality/safety of patient care. ClinicalTrials.gov registration: NCT02909322 (09-21-2016); Available at URL: https://clinicaltrials.gov/ct2/show/NCT0290932
- Published
- 2022
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