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Background: Transversus abdominis plane (TAP) block is considered a reliable locoregional technique for pain control after laparoscopic colorectal surgery. However, no clear benefit of TAP block over wound infiltration has been demonstrated by the current literature. This multicenter randomized clinical trial tested the non-inferiority of wound infiltration (WI) compared to WI plus laparoscopic-assisted TAP block (L-TAP).Methods: All patients with colorectal cancer and diverticular disease scheduled for laparoscopic resection at the Division of General and Hepatobiliary Surgery, University of Verona Hospital Trust, Verona, Italy and at the Colorectal Cancer Center, Kyungpook National University Medical Center, Kyungpook National University, Daegu, Korea, between April 2018 and March 2019 were considered for the trial. Patients were randomly allocated to either the WI group or the WI plus L-TAP group in a 1:1 allocation ratio. In total, 108 patients entered the study and 102 patients were analyzed; 50 patients received WI plus L-TAP and 52 patients received WI. The primary end point was the efficacy in pain control at 6 h measured according to Numeric Rating Scale (NRS). Secondary aims evaluated pain control at 12, 24, 48 and 72 h and other short-term results related to pain management.Results: Estimation of pain intensity at 6 h was comparable between the two groups (p = 0.16) with a mean (95% CI) difference in pain scores of 0.94 (- 0.13 to 2.02). No differences in pain scores were observed at other interval times or considering analgesic consumption, return of bowel function, postoperative complications and length of hospital stay.Conclusion: This study suggests that adding TAP block to WI does not affect pain control, amount of analgesics and other short-term outcomes.Trial Registration: NCT03376048 ( https://www.clinicaltrials.gov ). [ABSTRACT FROM AUTHOR]

Background: Transversus abdominis plane (TAP) block and wound infiltration (WI) are common locoregional anesthesia techniques for pain management in patients undergoing colorectal laparoscopic surgery. Comparative data between these two practices are conflicting, and a clear benefit of TAP block over WI is still debated. The main purpose of this study is to determine the efficacy in pain control of WI compared with WI plus laparoscopic TAP block (L-TAP) in cases of laparoscopic colorectal resection. Secondary aims are to evaluate other short-term results directly related to pain management: the need for rescue analgesic drugs, the incidence of postoperative nausea and vomiting, the resumption of gut functions, and the length of hospital stay.Methods/design: This is a prospective, randomized, controlled, two-arm, multicenter, single-blind study evaluating the efficacy of postoperative analgesic management of WI versus WI plus L-TAP in the context of laparoscopic colorectal surgery. Randomization is at the patient level, and participants are randomized 1:1 to receive either WI alone or WI plus L-TAP. Those eligible for inclusion were patients undergoing laparoscopic resection for colorectal tumor or diverticular disease at the Division of General and Hepatobiliary Surgery, Verona University, Verona, Italy, and at the Colorectal Cancer Center, Kyungpook National University, Daegu, Korea. Fifty-four patients are needed in each group to evidence a difference greater than 1 of 10 according to the numeric rating scale for pain assessment to establish that this difference would matter in practice.Discussion: The demonstration of a noninferiority of WI compared with WI plus L-TAP block would call into question TAP block usefulness in the setting of laparoscopic colorectal surgery.Trial Registration: ClinicalTrials.gov, NCT03376048 . Prospectively registered on 15 December 2017. [ABSTRACT FROM AUTHOR]