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临床试验/NCT04294329
NCT04294329已完成不适用

Pre-emptive Quadratus Lumborum Block for Laparoscopic Bariatric Surgery.A Prospective Randomizes Controlled Study.

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年8月15日最近更新:
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
入组人数
30
试验地点
1
主要终点
Postoperative pain severity

研究概览

简要总结

The purpose of this study was to determine the effectiveness of pre-emptive Quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients included in this study are
  • Both genders
  • Age between 18-50 years
  • Those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass).
  • BMI ≥ 35 Kg/m2 with comorbidity or ≥ 40 Kg/m2 without comorbidity.

排除标准

  • Patients excluded from this study were
  • those with obstructive sleep apnoea and/or Pickwickian syndrome.
  • if the laparoscopy procedure was converted to laparotomy.
  • patients suffering from known coagulation defects.
  • known hypersensitivity to bupivacaine, or those with contraindication to the use of NSAIDS.
  • Presence of sepsis at the site of injection.

研究组 & 干预措施

Group Quadratus lumborum block with bupivacaine

Experimental

After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose.

干预措施: US-guided Quadratus lumborum block. (Procedure)

Group Quadratus lumborum block with bupivacaine

Experimental

After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine where a solution of 0.25% bupivacaine 0.2 ml /kg (lean body weight) is used on each side with care not to exceed the toxic dose.

干预措施: Bupivacaine (Drug)

Group Quadratus lumborum block with saline

Placebo Comparator

After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side.

干预措施: US-guided Quadratus lumborum block. (Procedure)

Group Quadratus lumborum block with saline

Placebo Comparator

After induction of anesthesia a QLB (quadratus lumborum block) will be performed by using ultrasound machine.A volume of 0.2ml/kg normal saline will given for each side.

干预措施: Saline (Drug)

结局指标

主要结局

Postoperative pain severity

时间窗: 24 hours postoperatively

Assessment of analgesia intraoperatively and for the first 24 hours postoperatively using the numerical ratingscale (NRS)score .The scale ranges from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain imaginable.

次要结局

  • Total dose of opioids(24 hours postoperatively.)
  • Intraoperative hemodynamics(24 hours postoperatively)
  • Postoperative analgesic needs(24 hours postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Walid Nofal

Clinical professor

Ain Shams University

研究点 (1)

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