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临床试验/NCT02489851
NCT02489851已完成不适用

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study

Corniche Hospital2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
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 may produce extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.

The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block 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 72 patients (36 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 receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.

All the blocks 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.

All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

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

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 Sepsis 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

  • Severity of postoperative pain via visual analogue pain scale (VAS)(48 hours)
  • Nausea or vomiting(48 hours)
  • Sedation score(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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