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临床试验/NCT05386069
NCT05386069已完成3 期

The Effect of a Non-Opioid Multimodal Pain (NOMO) Protocol in Decreasing Narcotic Use After Urogynecologic Surgery

Prisma Health-Upstate1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年11月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
10
试验地点
1
主要终点
Morphine Milligram Equivalents Used During Inpatient Stay

研究概览

简要总结

The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

详细描述

The objective of this study is to evaluate narcotic use after implementation of a Non-Opioid Multimodal Pain (NOMO) protocol in patients who are undergoing a urogynecologic procedure. NOMO protocols seek to reduce the opioid usage for patients in the postoperative period. Patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. These medications are approved for pain control; but they have few side effects and less addictive properties. The study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). Study participants will be asked to utilize the validated Brief Pain Inventory (appendix A) scale to assess post-operative pain levels. Based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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

  • English-speaking females
  • greater than or equal to 18 years old
  • scheduled for a urogynecologic procedure at GHS requiring inpatient stay or extended observation.

排除标准

  • less than 18 years of age
  • non-English speaking patients
  • unscheduled urogynecologic surgeries
  • patients expected to undergo a simple reconstructive surgery with same-day discharge,
  • history of chronic pain
  • chronic Lyrica or Celebrex use
  • psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks
  • current liver disease
  • kidney disease (defined as GFR <60)
  • malignancy
  • sulfa allergy

研究组 & 干预措施

Treatment Arm

Active Comparator

Patients to receive standard weight-based ketamine bolus (0.5 mg/kg) at start of procedure, withhold opioids in post-operative period unless rescue medications fail

干预措施: NOMO Protocol (Drug)

结局指标

主要结局

Morphine Milligram Equivalents Used During Inpatient Stay

时间窗: from immediately postoperative through discharge or 4 weeks, whichever comes first

Total morphine milligram equivalents calculated for each patient during their stay.

次要结局

  • Passage of Voiding Trial(from immediately postoperative through discharge or 4 weeks, whichever comes first)
  • Anti-emetic Use(postoperative day 1 through day of discharge from hospital; all patients were dischard on post-op day 1)
  • Patient Pain Score(postoperative day 7)
  • Prescription for Opioid at Discharge(postoperative day 2 through postoperative day 7)
  • Length of Hospital Stay(postoperative day 1 through discharge or 4 weeks, whichever comes first)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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