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临床试验/NCT06120530
NCT06120530已完成4 期

Effect of Intraperitoneal Bupivacaine on Postoperative Pain Control in Patients Undergoing Pelvic Organ Prolapse Repair

Indiana University1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2023年8月16日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
91
试验地点
1
主要终点
Pain Score at 4 Hours

研究概览

简要总结

The purpose of this study is to evaluate the effects of 30 mL intraperitoneal Bupivacaine without epinephrine 0.25% on postoperative pain control in patients undergoing pelvic organ prolapse repair. The investigators hypothesize that use of intraperitoneal Bupivacaine will decrease postoperative pain scores and opiate consumption in the postoperative period, following pelvic organ prolapse repair.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intraperitoneal bupivacaine

Active Comparator

30 mL of bupivacaine without epinephrine 0.25%

干预措施: Bupivacaine (Drug)

placebo

Placebo Comparator

Saline

干预措施: Saline (Other)

结局指标

主要结局

Pain Score at 4 Hours

时间窗: 4 hours

Patient pain will be measured by means of a numeric rating scale (scale from 0-10 with lower numbers indicating less pain and higher numbers indicating more pain) at 4 hours after surgical pelvic organ prolapse repair

次要结局

  • Hospital Length of Stay(Up to 24 hours)
  • Total Opiate Consumption(First 24 hours postoperatively)
  • Pain Score at 8 Hours, 12 Hours and 24 Hours(8 hours, 12 hours and 24 hours)
  • Time to First Narcotic(Up to 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Ryan Stewart

Assistant Professor of Clinical Obstetrics & Gynecology

Indiana University

研究点 (1)

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