Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total morphine used in the first 48 hours after surgery
研究概览
简要总结
The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents produces extensive analgesia and prolonged action of the injected local anesthetic solution.
Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia.
The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management in patients who had cesarean section under spinal anesthesia.
详细描述
After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 25 patients per group was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.
Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to undergo QLB with Bupivacaine versus placebo(saline) after their surgery. Allocation will be done using closed envelope technique.
The study medications/placebo will be prepared and labelled by an anesthetist who is not involved in the study.
All patients will receive a standard spinal anesthetic. At the end of surgery , Quadratus lumborum block group (QL) patients will receive bilateral QLB with 0.125% bupivacaine.
Control group patients will receive a bilateral placebo block using saline. The block will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elective caesarean sections
- •ASA 1 to 3
- •Written informed consent.
排除标准
- •Patient refusal
- •Local infection at the site of injection
- •Allergy to study medications
- •Anatomic abnormalities
- •Systemic anticoagulation or coagulopathy
- •Inability to comprehend or participate in pain scoring system
- •Inability to use intravenous patient controlled analgesia
结局指标
主要结局
Total morphine used in the first 48 hours after surgery
时间窗: 48 hours
Total cumulative morphine dose in mg used in the first 48 hours after surgery
次要结局
- Nausea or vomiting(48 hours)
- Severity of postoperative pain via visual analogue pain scale(48 hours)
- Sedation score in the first 48 hours(48 hours)
研究者
Dr. Tarek Ansari
Consultant Anesthetist
Corniche Hospital