Preoperative Gabapentin for Vaginal Prolapse Procedures: A Randomized Trial.

IF 1.2 Q4 OBSTETRICS & GYNECOLOGY
Colin M Johnson, Kimberly A Kenne, Catherine S Bradley, Linder H Wendt, Joseph T Kowalski
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引用次数: 0

Abstract

Importance: Perioperative gabapentin is widely used in gynecology ERAS protocols, but evidence for its use for vaginal prolapse procedures is very limited.

Objective: The objective of this study was to evaluate the effect of preoperative gabapentin on postoperative opioid use in patients undergoing vaginal apical suspension procedures for pelvic organ prolapse.

Study design: This was a double-blind, randomized, placebo-controlled clinical trial conducted at a tertiary care center. Participants received either 300 mg of gabapentin or placebo 1 hour before surgery, along with 975 mg of acetaminophen and 400 mg of celecoxib. The primary outcome was total opioid consumption in the first 24 hours postoperatively in morphine milligram equivalents. Secondary outcomes included pain scores, time to discharge, adverse events, and adequacy of pain control. Statistical analysis included the Wilcoxon rank sum and Fisher exact tests. A sample size of 46 per group was planned to achieve 80% power.

Results: From January 2023 through October 2024, 110 participants were enrolled, and 100 were randomized and received the intervention (50 per group). Demographics and patient characteristics were similar between groups except for preoperative/intraoperative opioids. There were no significant differences between the placebo and gabapentin groups in postoperative 24-hour opioid use ( P =0.15) or any secondary outcomes. After correcting for the difference in preoperative/intraoperative opioid use with regression models, there were still no significant differences in the primary or secondary outcomes. The same results held true for a per-protocol analysis, which excluded 5 participants.

Conclusions: A single 300-mg preoperative dose of gabapentin did not significantly reduce opioid use or improve pain control in patients undergoing vaginal apical suspension. These findings suggest limited utility for the routine use of gabapentin in this clinical context.

术前加巴喷丁治疗阴道脱垂:随机试验。
重要性:围手术期加巴喷丁广泛用于妇科ERAS方案,但其用于阴道脱垂手术的证据非常有限。目的:本研究的目的是评估术前加巴喷丁对盆腔器官脱垂患者阴道根尖悬吊手术后阿片类药物使用的影响。研究设计:这是一项在三级保健中心进行的双盲、随机、安慰剂对照临床试验。参与者在手术前1小时接受300毫克加巴喷丁或安慰剂,同时服用975毫克对乙酰氨基酚和400毫克塞来昔布。主要结局是术后最初24小时内吗啡毫克当量阿片类药物的总消耗量。次要结局包括疼痛评分、出院时间、不良事件和疼痛控制的充分性。统计分析包括Wilcoxon秩和检验和Fisher精确检验。计划每组46个样本量,以达到80%的功率。结果:从2023年1月至2024年10月,共有110名受试者入组,其中100人随机接受干预(每组50人)。除了术前/术中阿片类药物外,两组间的人口统计学和患者特征相似。安慰剂组和加巴喷丁组在术后24小时阿片类药物使用(P=0.15)或任何次要结局方面无显著差异。在用回归模型校正了术前/术中阿片类药物使用的差异后,主要和次要结局仍然没有显著差异。同样的结果也适用于每个方案的分析,它排除了5名参与者。结论:术前单剂量300 mg加巴喷丁并不能显著减少阿片类药物的使用或改善阴道根尖悬浮术患者的疼痛控制。这些发现表明加巴喷丁在这种临床背景下常规使用的效用有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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CiteScore
2.80
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