Jinseok Yeo1,2, Jun Seok Park3,2, Gyu-Seog Choi3,2, Hye Jin Kim3,2, Jay Kyoung Kim1, Jinyoung Oh1,2, Soo Yeun Park4,5. 1. Department of Anesthesiology and Pain Medicine, Kyungpook National University Chilgok Hospital, Daegu, Korea. 2. School of Medicine, Kyungpook National University, Daegu, Korea. 3. Department of Colorectal Surgery, Kyungpook National University Chilgok Hospital, Daegu, Korea. 4. Department of Colorectal Surgery, Kyungpook National University Chilgok Hospital, Daegu, Korea. psy-flower@daum.net. 5. School of Medicine, Kyungpook National University, Daegu, Korea. psy-flower@daum.net.
Abstract
BACKGROUND: A multimodal analgesia (MMA) protocol has shown the effect of postoperative pain control and reduced the postoperative opioid consumption. However, it was questionable whether MMA could replace opioid-based patient-controlled analgesia (PCA) for postoperative pain control. Therefore, this study aimed to investigate whether an MMA protocol is non-inferior to opioid-based PCA for pain management after a minimally invasive colorectal cancer surgery. METHODS: A randomized, open-label, non-inferiority clinical trial was conducted on patients undergoing laparoscopic or robotic resection of colorectal cancer. The patients were randomly assigned to either the PCA or MMA group. The MMA protocol included pregabalin, tramadol, wound infiltration, and transversus abdominis plane block. The primary outcome was the numeric rating scale (NRS) score for pain at rest 24 h postoperatively. RESULTS: Ninety-seven patients were included in the intention-to-treat analysis. The mean difference in NRS score at rest at 24 h was 0.25 (95% confidence interval, - 0.61 to 1.11). This result demonstrated the non-inferiority of MMA to PCA in our non-inferiority margin (- 1). Compared with the PCA group, the median remifentanil dose (996 vs. 654 μg; p < 0.001) and time in the post-anesthesia care unit (35 vs. 25 min; p < 0.001) were significantly less in the MMA group. CONCLUSIONS: Our MMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA based on patient-reported pain intensity, with no significant increase in adverse events. These results will help construct a strategy to reduce conventional opioid prescriptions for pain management after a minimally invasive colorectal cancer surgery. Trial Registration Number Trial Registration Clinical Research Information Service Identifier: KCT0002593.
BACKGROUND: A multimodal analgesia (MMA) protocol has shown the effect of postoperative pain control and reduced the postoperative opioid consumption. However, it was questionable whether MMA could replace opioid-based patient-controlled analgesia (PCA) for postoperative pain control. Therefore, this study aimed to investigate whether an MMA protocol is non-inferior to opioid-based PCA for pain management after a minimally invasive colorectal cancer surgery. METHODS: A randomized, open-label, non-inferiority clinical trial was conducted on patients undergoing laparoscopic or robotic resection of colorectal cancer. The patients were randomly assigned to either the PCA or MMA group. The MMA protocol included pregabalin, tramadol, wound infiltration, and transversus abdominis plane block. The primary outcome was the numeric rating scale (NRS) score for pain at rest 24 h postoperatively. RESULTS: Ninety-seven patients were included in the intention-to-treat analysis. The mean difference in NRS score at rest at 24 h was 0.25 (95% confidence interval, - 0.61 to 1.11). This result demonstrated the non-inferiority of MMA to PCA in our non-inferiority margin (- 1). Compared with the PCA group, the median remifentanil dose (996 vs. 654 μg; p < 0.001) and time in the post-anesthesia care unit (35 vs. 25 min; p < 0.001) were significantly less in the MMA group. CONCLUSIONS: Our MMA protocol successfully controlled postoperative pain and was non-inferior to morphine-based PCA based on patient-reported pain intensity, with no significant increase in adverse events. These results will help construct a strategy to reduce conventional opioid prescriptions for pain management after a minimally invasive colorectal cancer surgery. Trial Registration Number Trial Registration Clinical Research Information Service Identifier: KCT0002593.
Authors: Jay Soong-Jin Lee; Hsou Mei Hu; Anthony L Edelman; Chad M Brummett; Michael J Englesbe; Jennifer F Waljee; Jeffrey B Smerage; Jennifer J Griggs; Hari Nathan; Jacqueline S Jeruss; Lesly A Dossett Journal: J Clin Oncol Date: 2017-10-19 Impact factor: 44.544
Authors: Marco Echeverria-Villalobos; Nicoleta Stoicea; Alexandre B Todeschini; Juan Fiorda-Diaz; Alberto A Uribe; Tristan Weaver; Sergio D Bergese Journal: Clin J Pain Date: 2020-03 Impact factor: 3.442