Do Elastic Abdominal Binders Reduce Post Operative Pain and Blood Loss?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Average Pain Level Postoperative
研究概览
简要总结
This is a pilot study investigating the use of abdominal binders after cesarean sections. The researchers are testing whether elastic abdominal binders improve postoperative pain control and reduce postoperative blood loss. Blood loss and pain control are both concerns after giving birth. It is hoped that the use of an abdominal binder after giving birth will provide a non-pharmacologic way to to reduce blood loss and manage pain.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Cesarean section at term (at least 39 weeks gestation) scheduled in advance
- •Singleton gestation confirmed by ultrasound in the current pregnancy
- •Body mass index 20-40 kg/m2 (at first prenatal visit or pre-pregnancy)
- •None of these pregnancy complications in the current pregnancy:
- •bleeding disorder or use of anticoagulants other than low-dose heparin
- •abnormal placenta (placenta previa or accrete)
- •Preoperative hemoglobin less than 10 mg/dL
- •Chorioamnionitis (intrauterine infection)
- •No chronic pain syndrome (defined as participating in formal chronic pain management within the past year)
- •Able to read English and understand spoken English
排除标准
- •Onset of labor prior to time when the cesarean was scheduled
- •Complications during performance of cesarean or discovered during cesarean:
- •placenta accreta, increta, or percreta
- •vasa previa
- •cesarean hysterectomy required for severe hemorrhage
- •organ damage during cesarean (cystotomy, enterotomy, ureteral injury)
结局指标
主要结局
Average Pain Level Postoperative
时间窗: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure average pain level postoperative. The pain assessment was self-administered. Average pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Reported average pain level is reported as means for each participant group.
Worst Pain Level Postoperative
时间窗: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure worst pain level postoperative. The pain assessment was self-administered. Worst pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Worst pain level is reported as means for each participant group.
Lowest Pain Level Postoperative
时间窗: 24 hours postoperative
SF-MPQ2 Pain assessment scale was used to measure lowest pain level postoperative. The pain assessment was self-administered. Lowest pain was reported using a 0 to 10 scale, with 0 being "no pain" and 10 being "pain as bad as you can imagine." Lowest pain level is reported as means for each participant group.
次要结局
- Change in Hemoglobin Concentration(24 hours from baseline)
研究者
Zachary Kuhlmann, DO
Principal Investigator
University of Kansas Medical Center