临床试验/NCT05494385

NCT05494385已完成4 期

Effect of Perioperative Gabapentin on Postoperative Opioid Requirements

Indiana University1 个研究点分布在 1 个国家目标入组 114 人开始时间: 2021年7月27日最近更新: 2024年10月23日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Indiana University
入组人数: 114
试验地点: 1
主要终点: Opioid Prescription at Discharge

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.

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 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Women > 18 years old
•English-speaking
•Stage > 2 pelvic organ prolapse
•Undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure)
•Planning overnight stay

排除标准

•Renal dysfunction (creatinine clearance <60 mL/min)
•Allergy to acetaminophen and ibuprofen
•Allergy to gabapentin
•Patients on a Controlled Substance Agreement or Opioid Contract from another provider. This information is available in the IU Health electronic medical record, Cerner.

研究组 & 干预措施

Preoperative Gabapentin/Postoperative Placebo

Placebo Comparator

干预措施: Preoperative Gabapentin/Postoperative Placebo (Drug)

Preoperative Gabapentin/Postoperative Gabapentin

Active Comparator

干预措施: Preoperative Gabapentin/Postoperative Gabapentin (Drug)

结局指标

主要结局

Opioid Prescription at Discharge

时间窗: Length of postoperative hospital stay (at discharge, an average of 32 hours from time of registration for surgery)

Percentage of patients requiring an opioid prescription at discharge in each group. Patients who use 5 or more doses of PRN opioids during inpatient postoperative course will receive a prescription for opioids.

次要结局

Opioid Refill Requests(6 weeks)
Inpatient Pain Scores(Length of postoperative hospital stay (an average of 32 hours following surgery))
Inpatient Morphine Milligram Equivalents(Length of postoperative hospital stay (an average of 32 hours following surgery))
Length of Stay(Time of registration for surgery to time of discharge from hospital)
Nausea(Length of postoperative hospital stay (an average of 32 hours following surgery))
Sedation(On postoperative day 1 between 6AM and 10AM)

研究者

发起方

Indiana University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Douglass Hale

Adjunct Clinical Professor

Indiana University

研究点 (1)

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