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临床试验/NCT03308955
NCT03308955已完成不适用

Analgesic Effect of Ultrasound Guided Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery

Bursa Yüksek İhtisas Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月22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
发起方
入组人数
60
试验地点
1
主要终点
Visual Analog Pain Scale

研究概览

简要总结

Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime.

This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.

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
Single (Participant)

盲法说明

Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy

排除标准

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.

研究组 & 干预措施

Grup B

Active Comparator

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: Tramadol (Drug)

Grup B

Active Comparator

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: Ultrasound guided Quadratus Lumborum block (Procedure)

Grup S

Sham Comparator

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: Tramadol (Drug)

Grup S

Sham Comparator

Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+ 400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

干预措施: Ultrasound guided placebo Quadratus Lumborum block (Procedure)

结局指标

主要结局

Visual Analog Pain Scale

时间窗: Postoperative 24 hours

Visual Analog Pain Scale was used for pain

次要结局

  • tramadol consumption(Postoperative 24 hours)
  • side effect profile scores)(Postoperative 24 hour)
  • additional analgesic use(Postoperative 24 hour)

研究者

发起方
Bursa Yüksek İhtisas Education and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Korgün Ökmen

Principal Investigator

Bursa Yüksek İhtisas Education and Research Hospital

研究点 (1)

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