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Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TQL block with saline
TQL block with Bupivacaine
TQL block with Bupivacaine and dexamethasone
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Quadratus Lumborum Block, Laparoscopic Cholecystectomy, dexamethasone

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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/m2.
  • Emergency laparoscopic cholecystectomy
  • If laparoscopic procedure converted to open.

Sites / Locations

  • Minya University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

saline

Bupivacaine

Bupivacaine and dexamethasone

Arm Description

bilateral quadratus lumborum block using 0.9% normal saline

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%

bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

postoperative Nalbuphine
Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)
intraoperative fentanyl
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
Postoperative pain severity will be assessed using VAPS
The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
side effects
Incidence of postoperative nausea and vomiting

Full Information

First Posted
May 8, 2019
Last Updated
July 29, 2023
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT03956966
Brief Title
Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy
Official Title
Ultrasound-guided Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Quadratus Lumborum Block, Laparoscopic Cholecystectomy, dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double blind
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saline
Arm Type
Placebo Comparator
Arm Description
bilateral quadratus lumborum block using 0.9% normal saline
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25%
Arm Title
Bupivacaine and dexamethasone
Arm Type
Active Comparator
Arm Description
bilateral quadratus lumborum block using Bupivacaine hydrochloride 0.25% and dexamethasone
Intervention Type
Drug
Intervention Name(s)
TQL block with saline
Other Intervention Name(s)
C Group
Intervention Description
drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours. Drug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided
Intervention Type
Drug
Intervention Name(s)
TQL block with Bupivacaine
Other Intervention Name(s)
B Group
Intervention Description
Drug: saline 1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours. Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block
Intervention Type
Drug
Intervention Name(s)
TQL block with Bupivacaine and dexamethasone
Other Intervention Name(s)
D Group
Intervention Description
Drug: dexamethasone 1 mL dexamethasone "4mg" administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes. Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours. Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3. Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block
Primary Outcome Measure Information:
Title
Time for first request to rescue analgesia
Description
Time for the first request to rescue analgesia (in minutes)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative Nalbuphine
Description
Cumulative postoperative Nalbuphine consumption (total dose given in milligrams)
Time Frame
24 hours after surgery
Title
intraoperative fentanyl
Description
Cumulative intraoperative fentanyl consumption (total dose given in micrograms)
Time Frame
For 4 hours after start of anaesthesia
Title
Postoperative pain severity will be assessed using VAPS
Description
The severity of postoperative pain will be measured and recorded by using the visual analogue scale (VAPS) for pain, where 0 is equal to no pain and 10 indicates the worst possible pain
Time Frame
For 24 hours after surgery
Title
side effects
Description
Incidence of postoperative nausea and vomiting
Time Frame
For 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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/m2. Emergency laparoscopic cholecystectomy If laparoscopic procedure converted to open.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidy S Mansour, MD
Organizational Affiliation
assistant professor of Anesthesia and Surgical Intensive Care
Official's Role
Study Director
Facility Information:
Facility Name
Minya University
City
Minya
ZIP/Postal Code
61519
Country
Egypt

12. IPD Sharing Statement

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Quadratus Luborum Block Using Bupivacaine Versus Bupivacaine-Dexamethasone in Laparoscopic Cholecystectomy

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