A prospective randomized trial comparing the efficacy of temperature-responsive gel with local anesthetics versus local anesthetic infusion pump device for postoperative pain control after bariatric surgery.
Mira Yoo, Du-Yeong Hwang, Guan Hong Min, Heeyoung Lee, So Hyun Kang, Sang-Hoon Ahn, Yun-Suhk Suh, Young Suk Park
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引用次数: 0
Abstract
Purpose: Bariatric surgery is the gold standard for the treatment of morbid obesity, but postoperative pain impedes recovery. Currently available pain-recovery treatments have patient safety concerns. This led to a noninferiority study of Welpass (Genewel Co., Ltd.) vs. On-Q PainBuster (B. Braun), each used alongside a traditional method of continuous local anesthetic administration, in patients undergoing bariatric surgery.
Methods: In this single-center prospective randomized clinical trial, patients were assigned in a 1:1 ratio to the treatment group (Welpass) and the control group (On-Q PainBuster), with ketorolac administered as needed after surgery according to the protocol. To assess efficacy, the total amount of ketorolac used up to 72 hours postoperatively was measured. Additionally, ketorolac usage and numerical rating scales (NRS) were recorded at 6, 24, 48, and 72 hours after operation.
Results: The total amounts of ketorolac used in the 72 hours postoperatively were 188.0 ± 84.6 mg in the treatment group and 198.7 ± 50.0 mg in the control group. The efficacy of the treatment group was noninferior to that of the control group, since the lower limit (-29.9 mg) of the confidence interval for the difference with the control group was greater than the prespecified noninferiority margin (-35.0 mg). Furthermore, when the NRS was evaluated after bariatric surgery, there was no significant difference in scores between the 2 groups at each time point (P > 0.05).
Conclusion: We found no difference in effect on pain between the 2 groups, supporting the use of Welpass in clinical practice for pain management in patients undergoing bariatric surgery.
期刊介绍:
Manuscripts to the Annals of Surgical Treatment and Research (Ann Surg Treat Res) should be written in English according to the instructions for authors. If the details are not described below, the style should follow the Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publications available at International Committee of Medical Journal Editors (ICMJE) website (http://www.icmje.org).