跳至主要内容
临床试验/NCT03341533
NCT03341533已完成不适用

Abdominal Ice Packs for Pain Control and Reduction of Narcotic Use Following Laparoscopic Hysterectomy: A Randomized Controlled Trial

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2018年1月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
142
试验地点
2
主要终点
Numeric Pain Intensity Scale

研究概览

简要总结

The purpose of this study is to evaluate the effect of using ice packs on the abdomen immediately after laparoscopic hysterectomy surgery on pain control and narcotic pain medication use.

详细描述

Hysterectomy is one of the most common surgical procedures performed on women in the United States, with approximately 600,000 performed annually. The use of postoperative cooling as an adjuvant for post-operative pain control has previously been shown to be effective and safe in a variety of procedures, but has yet to be described for laparoscopic surgery. In contrast to laparotomy where the wound is a significant pain generator and direct application of ice is intuitive, in laparoscopic surgery much of the pain-generating tissue trauma is intraperitoneal and pelvic in nature, away from the abdominal wall. Ice pack use on the abdominal wall likely inhibits visceral afferent pain fibers via somatic afferent nerve cross-talk. Accordingly, applying ice to the abdominal wall and its somatic afferents may improve laparoscopic pain control, despite the lack of a significant abdominal wound. Our goal is to quantify narcotic use after hospital discharge following hysterectomy, and evaluate the effectiveness of abdominal ice packs as low cost adjuncts for pain control.

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

  • Women undergoing robotic or conventional laparoscopic hysterectomy

排除标准

  • Any opioid use within 2 weeks of surgery date
  • Planned post-operative ICU admission
  • Conversion of laparoscopic approach to laparotomy or any incision ≥4 cm
  • Regional anesthesia/analgesia, including tap block use

结局指标

主要结局

Numeric Pain Intensity Scale

时间窗: 12 hours post-operatively

Self-reported pain intensity scores (Numerical Pain Intensity Scale, 0-10 visual analog scale with 0 representing no pain and 10 representing the worst pain imaginable) assessed and documented a minimum every four hours post-operatively. Mean differences of pain intensity assessed between ice group and usual care group.

Mean Morphine Metabolic Equivalents (MME) Consumption: Inpatient Floor

时间窗: an average of one day from entering hospital floor to discharge

Calculation of average patient MME from the time enter hospital floor to hospital discharge. Administered narcotics will be abstracted from the medical record and converted to total MME for analysis.

次要结局

  • Mean Morphine Metabolic Equivalents (MME) Consumption: Outpatient(2 weeks)
  • Brief Pain Inventory Short Form - Postoperative Pain Severity(one day after surgery)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tatnai L. Burnett

Senior Associate Consultant

Mayo Clinic

研究点 (2)

Loading locations...

相似试验