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临床试验/NCT02932930
NCT02932930已完成不适用

Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study

St Joseph University, Beirut, Lebanon1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Cumulative morphine consumption

研究概览

简要总结

The original concept of a quadratus lumborum block (QLB) indicated for analgesia after abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP blocks have already been proved effective in urologic, abdominal, and gynecologic procedures by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount of postoperative analgesic medication. The main advantages of QLB compared to the TAP block is a wider sensory block area and a longer duration of analgesia. This is due to the extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral space(4).

Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. However, there are no published reports on QLB for postoperative pain after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline. Post-operative cumulative analgesic medication consumption, pain severity at rest and on movement, as well as quality of recovery will be evaluated and compared in both groups.

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

性别
Female
接受健康志愿者

入选标准

  • Standard abdominoplasty procedure
  • Written informed consent
  • Age ≥ 18 years

排除标准

  • Patient's refusal
  • Allergies to any study medication
  • Inability to comprehend or participate in scoring scales
  • Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane
  • Quadratus lumborum muscle plane not seen in ultrasound examination
  • Coagulopathy or on anticoagulants

研究组 & 干预措施

QLB group

Active Comparator

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.2% ropivacaine bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Ropivacaine, 0.2 ml/kg of 0.2% ropivacaine

干预措施: QLB bloc (Procedure)

QLB group

Active Comparator

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.2% ropivacaine bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Ropivacaine, 0.2 ml/kg of 0.2% ropivacaine

干预措施: 0.2% Ropivacaine (Drug)

Control group

Placebo Comparator

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.9% normal saline bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Normal saline, 0.2 ml/kg of 0.9 % normal saline

干预措施: QLB bloc (Procedure)

Control group

Placebo Comparator

Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.9% normal saline bilaterally.

Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Normal saline, 0.2 ml/kg of 0.9 % normal saline

干预措施: 0.9% normal saline (Drug)

结局指标

主要结局

Cumulative morphine consumption

时间窗: up to 48 hour

Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.

次要结局

  • Time to first tramadol dose(up to 48 hour)
  • Postoperative pain severity(up to 48 hour)
  • Quality of recovery(up to 48 hour)
  • Postoperative dynamic pain severity(up to 48 hour)
  • Nausea or vomiting(up to 48 hour)
  • Sedation level(up to 48 hour)
  • Time to first walk(up to 48 hour)

研究者

发起方
St Joseph University, Beirut, Lebanon
申办方类型
Other
责任方
Principal Investigator
主要研究者

samer jabbour

MD

St Joseph University, Beirut, Lebanon

研究点 (1)

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