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临床试验/NCT04491617
NCT04491617已完成不适用

STandard Versus No Opioid Prescription After Prolapse and Anti-INcontinence Surgery: A Randomized Controlled, Non-inferiority Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 148 人开始时间: 2020年8月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
148
试验地点
2
主要终点
Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit

研究概览

简要总结

Overprescribing opioids is considered a major contributor to the opioid crisis. Hill et al. demonstrated that within a general surgery practice, over 70% of the prescribed opioid pills were never taken. Disturbingly, 45% of patients who did not take opioids at all on their day of discharge were discharged with an opioid prescription (Chen et al). Recent initiatives have attempted to utilize restrictive opioid prescribing protocols for postoperative pain management in which patients were prescribed a limited number of opioid tablets (Hallway et al) or prescribed opioids only if they were used as an inpatient (Mark et al). These well-conducted studies show that restrictive opioid prescribing policies achieve the goal of reducing excess opioid exposure without causing undue harm, inconvenience or dissatisfaction among patients.

The objective of this study is to determine if a restrictive opioid prescription protocol (in which patients are not prescribed postoperative opioids unless they request them) is acceptable to patients after ambulatory and major urogynecologic surgery, compared to standard opioid prescribing practices. The study investigators believe that physicians can capitalize on the new ability to electronically prescribe opioids for patients who require them, to prevent over-prescribing without impacting patient care. The study also intends to describe postoperative opioid use patterns in the urogynecologic population, including factors predictive of opioid use and non-use. The results of this research will have a significant and timely impact by helping to reduce opioid overprescribing and informing future prescribing guidelines in the field of urogynecology.

详细描述

Specific Aims

Aim 1. To compare patient satisfaction and pain control using two different opioid prescribing protocols.

The study investigators hypothesize that postoperative pain control and satisfaction will be non-inferior between patients not routinely prescribed opioids after surgery and those prescribed a standard quantity. Participants will be asked to rate their pain control during the first 7 postoperative days with validated questionnaires. Participants' satisfaction with pain control will be evaluated at their postoperative visit.

Aim 2. To examine opioid use patterns after ambulatory and major urogynecologic surgery.

The study investigators hypothesize that most postoperative patients will use few or no opioids after urogynecologic surgery, regardless of prescribing protocol. All participants will receive thorough counseling with detailed instructions on non-opioid pain management, as well as multimodal analgesia via ERAS protocol during the perioperative period. Participants will be asked to log their opioid and non-opioid medication use in the first postoperative week. The investigators will also assess the number of requests for opioid prescription (in those randomized to the restrictive protocol) and opioid refills (from patients in the standard protocol).

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
None

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

  • Age greater than 18 years old
  • Access to ancillary care, including phone advice, nurse and outpatient clinic numbers
  • Transportation to outpatient clinic or ability to access Virtual Care Visits
  • Able to speak and read English
  • Has decision-making capacity and able to provide consent for research participation

排除标准

  • History of substance abuse disorder
  • Chronic opioid use
  • Score greater than or equal to 30 on Pain Catastrophizing Scale
  • Allergy (not intolerance) to greater than or equal to 2 opioids
  • Contraindications to both NSAIDs and acetaminophen
  • Surgery scheduled on Friday or before major federal holiday
  • Patients undergoing concomitant colorectal procedures
  • Patients with perioperative complication (such as iatrogenic bowel and bladder injury, hemorrhage, unanticipated laparotomy or ICU admission)

结局指标

主要结局

Percentage of Patients Satisfied With Pain Control at 6 Week Postoperative Visit

时间窗: 6-weeks

The proportion of patients satisfied with postoperative pain control will be reported. Patient satisfaction with pain control was assessed with a 5-point Likert scale at the postoperative visit ("Overall, how satisfied were you with your postoperative pain medication?" \[ranked 1- Very Dissatisfied to 5- Very Satisfied\] and those who ranked their satisfaction level as a 4 or 5 were considered satisfied.

次要结局

  • Number of Participants Who Requested a New Opioid Prescription or Opioid Refill(6-weeks)
  • Pain Level Scores During First Postoperative Week(1-week)
  • Opioid Usage in the First Postoperative Week(1-week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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