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临床试验/NCT05702827
NCT05702827已完成3 期

Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery

TriHealth Inc.2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2023年1月23日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
148
试验地点
2
主要终点
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery

研究概览

简要总结

This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair)
  • English as first language

排除标准

  • patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy
  • NSAID use within 7 days of surgery
  • steroid use within 10 days
  • daily opioid use in the last 3 months
  • long acting opioids within 3 days
  • any opioids within 24h
  • patients unable to consent for themselves
  • patients allergic to meloxicam or bupivacaine
  • pregnant or lactating patients

研究组 & 干预措施

bupivacaine-meloxicam

Experimental

All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group

干预措施: Bupivacaine-Meloxicam (Drug)

结局指标

主要结局

To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery

时间窗: 72 hours post surgery

Pain medication diary

次要结局

  • Compare worst pain on each day post operatively(72 hours post surgery)
  • Compare average pain on each day post operatively(72 hours post surgery)
  • Compare satisfaction with pain control post operatively(72 hours post surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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