A Randomized Trial of the Analgesic Efficacy of Wound Infiltration With Tramadol After Cesarean Delivery Under General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome measure in this study was cumulative morphine consumption.
研究概览
简要总结
This double-blind, randomized trial examined whether tramadol wound infiltration decreased postoperative pain following cesarean delivery under general anesthesia or reduced the need for analgesics in the immediate postoperative period. Patients in the tramadol group consumed significantly less morphine at all time intervals than those in the control group. The investigators suggest that the use of wound infiltration with tramadol may be a useful technique in patients who undergo cesarean section under general anesthesia to reduce postoperative pain, improve recovery, and facilitate early contact of mothers with their babies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparity
- •Gestation age between 37-40 weeks
- •CS under general anesthesia
排除标准
- •Pre-eclampsia
- •Cardiovascular problems
- •Allergy to any of the study medications
- •Chronic preoperative pain
- •Regular analgesic use
研究组 & 干预措施
the tramadol group
A preprepared 20 ml solution (tramadol 2 mgkg-1 within a 0.9% saline solution) was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
干预措施: Tramadol (Drug)
结局指标
主要结局
The primary outcome measure in this study was cumulative morphine consumption.
时间窗: postoperative 24 hours
The measure of need for analgesics in the immediate postoperative period in this study was cumulative morphine consumption.
次要结局
未报告次要终点
研究者
Murat Haliloglu
Medical doctor
Yeditepe University Hospital