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临床试验/NCT03711994
NCT03711994终止不适用

Cold Therapy for Pain Control Following Caesarean Section at Erlanger Baroness Hospital

University of Tennessee2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Post Operative Pain

研究概览

简要总结

Cold Therapy has been used for a variety of procedures and has been studied in several but not recently studied for reducing postop pain following Caesarean Sections. The hypothesis is that Cold Therapy will reduce postop pain and increase patients mobility and improve care of her newborn.

详细描述

Cesarean Section (C/S) is one of the most commonly performed surgeries in many parts of the world. In the United States the C/S rate in 1965 was 4.5% and increased to 30.5% in 2010. While the number of C/S has increased, pain management has primarily been via epidural, spinal, local and general anesthesia and narcotic medication for the immediate postpartum period (pp). This has lead to an increase in associated cost and problems with pain management. Limited studies have been performed to evaluate cold compresses on pain relief in the immediate pp and there potential to reduce cost. Cold Therapy (CT) is most often utilized in orthopedics, sports medicine, and in general surgery. CT has been used to improve range of motion (rom) and reduce pain medication utilization. We surmise CT may be useful in decreasing narcotic utilization after C/S, as well as improve mobility and allow for improved care of the newborn. This is significant as Erlanger Baroness Hospital (EBH) is becoming Baby Friendly (BF). This is a National Initiative for Children's Healthcare Quality (NICHQ) which desires having babies rooming in with their mothers and increasing breastfeeding rates. The goal of this study is to evaluate a newer sterile delivery system for decreasing pp pain via CT. This will be done as a Randomized Controlled Trial (RCT).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
16 Years 至 43 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • greater than 36 weeks gestation
  • primary C/S with Epidural for labor problems or breech presentation
  • Repeat C/S with spinal

排除标准

  • less than 36.0 week gestations
  • vertical skin incisions
  • classical or vertical hysterotomy incisions
  • failed vaginal births after C/S (VBAC)
  • past history of drug or alcohol abuse
  • positive drug screens unless medical prescribed drugs
  • general anesthesia
  • Caesarean Hysterectomy
  • primary C/S with spinal anesthesia

结局指标

主要结局

Post Operative Pain

时间窗: 48 hours after surgery

Will Utilize Visual Analog Scales to evaluate and measure pain in the post operative period.

次要结局

  • Narcotic Utilization(48 hours after surgrey)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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