Comparison of Lumbar Epidural Analgesia, Transversus Abdominis Plane Block and Wound Infiltration for Postoperative Pain Relief in Major Abdominal Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 81
- 试验地点
- 3
- 主要终点
- morphine consumption
研究概览
简要总结
The aim of our study was to compare the effects of Lomber Epidural Analgesia (LEA), Transversus Abdominis Plane (TAP) block and Local Anesthetic Infiltration (LAI) on postoperative morphine consumption, time to first recue analgesic request, pain and patient satisfaction scores and side effects were compared in the patients undergoing major gynecologic/oncology lower abdominal surgery.
详细描述
Following faculty ethical committee approval and written informed consent, 81 patients were included in our prospective, randomized and double-blind study. Patients were divided into 3 groups: lumbar epidural block (Group E), TAP block (Group T), and wound infiltration (Group I). Demographic data, surgical characteristics, hemodynamic values, pain scores at rest and on movement, morphine consumption, additional analgesic requirement, side effects at 1, 2, 6, 12, 24, 36 and 48th hours after surgery, and patient satisfaction scores at 24 and 48th hours were recorded.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA I-II,
- •between the age of 18-69,
- •undergoing major gynecological abdominal surgery under general anesthesia
排除标准
- •lack of patient consent
- •ASA > III
- •sensitivity or contraindication to study drugs
- •conditions in which epidural anesthesia is contraindicated
- •emergency and urgent surgery
- •inability to comprehend pain scale
- •any contraindication to the use of patient controlled analgesia (PCA) device.
结局指标
主要结局
morphine consumption
时间窗: change from baseline morphine comsumption at 48 hours
At the end of the surgery, the patients were allowed to use the patient controlled analgesia device (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc. St. Paul, MN) was prepared with 40 mg morphine HCl in 100 ml saline. The PCA doses of morphine consisted of a bolus dose of 0.02 mg/kg every 15 minutes without a background infusion. Morphine consumption (mg) was evaluated and recorded postoperative 48 hours.
次要结局
- time to first rescue analgesic(postoperative 48 hours)
- pain scores(change from baseline pain scores at 48 hours)
- side effects(postoperative 48 hours)
- patient satisfaction score(postoperative 24 and 48 hours)
研究者
Hakki Unlugenc
professor
Cukurova University