Protocol For The Randomized Controlled Trial Of Pulsed Short Wave Therapy In Cesarean Section
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Medication Use
研究概览
简要总结
This clinical study is designed to assesses the benefit of adding pulsed shortwave therapy to the postoperative pain and recovery protocol following Cesarean section. Pulsed shortwave therapy is a safe adjunct pain therapy for acute and chronic pain.
详细描述
Pain is ranked highest among undesirable clinical outcomes associated with caesarean section therefore postoperative pain relief following a cesarean section is extremely important to optimize maternal and neonate well being. Multimodial analgesics are effective in reducing postoperative pain but analgesia is still not optimized. Opiate based analgesics are effective but having troubling side effects. Addition of non-drug pain therapies hold promise in improving postoperative recovery while potentially allowing for reduced use of drug based analgesics.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Voluntarily
- •Performed using spinal anesthesia
- •ASA I (Normal healthy patients) and II (Patients with mild systemic disease) (as defined by the American Society of Anesthesiologists Physical Status Classification system)
- •PARA 0000, 1, 2, 3 [i.e. First, Second, or Third C-Section)
- •At term pregnancy (>38 weeks)
- •Age between 18 - 50 years
排除标准
- •Longitudinal surgical incision
- •Placental abnormalities noted
- •Time of extraction of the fetus >10 min from cutaneous incision
- •Blood loss during surgery of >800 ml
- •Any of the conditions not considered in inclusion criteria
研究组 & 干预措施
Active Group
Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as an active RecoveryRx Pulsed Short Wave Therapy device.
干预措施: RecoveryRx (Device)
Control Group
Patients in this group will be treated with the currently used standard protocol for the control of post-operative pain as well as a sham RecoveryRx Pulsed Short Wave Therapy device.
干预措施: Sham RecoveryRx (Device)
结局指标
主要结局
Medication Use
时间窗: Data collected daily for 7 Days
Quantify the use of analgesic medications during 7 days of postoperative recovery.
次要结局
- Time to patient Patient Mobility(2 Days)
- Would Closure at Day 7, Wound Complications(7 Days)
- Change in Visual Analogue Pain(Data collected for 7 Days)