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Clinical Trials/NCT03956966
NCT03956966
Completed
Not Applicable

Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy

Minia University1 site in 1 country90 target enrollmentNovember 20, 2018

Overview

Phase
Not Applicable
Intervention
TQL block with saline
Conditions
Post Operative Pain
Sponsor
Minia University
Enrollment
90
Locations
1
Primary Endpoint
Time for first request to rescue analgesia
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The aim of the present study was to compare the effectiveness of transmuscular Quadratus Lumborum block using Bupivacaine versus Bupivacaine- Dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy.

Because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. Quadratus lumborum block (QLB) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. Dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor C fibers transmission could be used as a local anesthetic adjuvant.

Detailed Description

The patients were randomly allocated into three groups each contains (30) patient. Control group (C) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1mL 0.9% normal saline) in each side ,Bupivacaine group (B) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1mL 0.9% normal saline) in each side and Dexamethasone-Bupivacaine group (D) received bilateral quadratus lumborum block using (20 ml Bupivacaine hydrochloride 0.25% + 1 mL dexamethasone "4mg") in each side. The following variables: heart Rate, mean arterial Blood Pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total Analgesic requirement in the first 24 hours, patient satisfaction and complications were Recorded and compared between groups.

Registry
clinicaltrials.gov
Start Date
November 20, 2018
End Date
September 1, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minia University
Responsible Party
Principal Investigator
Principal Investigator

haidy salah mansour

principle investigator

Minia University

Eligibility Criteria

Inclusion Criteria

  • American Physical Status I or II
  • Elective laparoscopic Cholecystectomy

Exclusion Criteria

  • Patient refusal.
  • Hematological diseases
  • Bleeding disorders.
  • Coagulation abnormality.
  • Psychiatric diseases.
  • Local skin infection
  • Sepsis at site of the block.
  • Known intolerance to the study drugs.
  • Body Mass Index \> 40 Kg/m
  • Emergency laparoscopic cholecystectomy

Arms & Interventions

saline

bilateral quadratus lumborum block using 0.9% normal saline

Intervention: TQL block with saline

Bupivacaine

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%

Intervention: TQL block with Bupivacaine

Bupivacaine and dexamethasone

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone

Intervention: TQL block with Bupivacaine and dexamethasone

Outcomes

Primary Outcomes

Time for first request to rescue analgesia

Time Frame: 24 hours

Time for the first request to rescue analgesia (in minutes)

Secondary Outcomes

  • intraoperative fentanyl(For 4 hours after start of anaesthesia)
  • side effects(For 24 hours after surgery)
  • postoperative Nalbuphine(24 hours after surgery)
  • Postoperative pain severity will be assessed using VAPS(For 24 hours after surgery)

Study Sites (1)

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