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临床试验/NCT05918796
NCT05918796已完成1 期

Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
measuring the time interval required till the first analgesic dose

研究概览

简要总结

The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

详细描述

Background: The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.

Objective

To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.

Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy surgeries under general anesthesia were included in this study, they were divided into two groups. Group A (perineural dexamethasone and bupivacaine group) [n=30] Those cases will receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25% concentration. Group B (perineural bupivacaine group) [n=30] Those cases will receive perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aging > 18 years of both sexes.
  • Patients undergoing Laparoscopic cholecystectomy surgeries (duration of operation 50-80 minutes).
  • ASA physical status classes I - II.

排除标准

  • Patient's refusal of procedure or participation in the study.
  • ASA classes III or above.
  • Coagulopathy and bleeding disorders.
  • Local skin infections
  • Body mass index >40kg/m2

研究组 & 干预措施

bupivacaine

Active Comparator

ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally.

干预措施: Bupivacaine (Drug)

bupivacaine and dexamethasone

Active Comparator

ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.

干预措施: Bupivacaine (Drug)

bupivacaine and dexamethasone

Active Comparator

ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.

干预措施: Dexamethasone (Drug)

结局指标

主要结局

measuring the time interval required till the first analgesic dose

时间窗: the first 24 hours

to reach a numeric rating scale NRS Pain score ≥4

次要结局

  • total pethidine dose received(total pethidine dose received in 24 hours)
  • mean blood pressure(will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.)
  • heart rate changes(will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.)
  • Incidence of side effects(record any side effect over 24 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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