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Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine
Dexamethasone
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post Operative Pain focused on measuring bupivacaine, dexamethasone, quadratus lumborum block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

bupivacaine

bupivacaine and dexamethasone

Arm Description

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

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

Outcomes

Primary Outcome Measures

measuring the time interval required till the first analgesic dose
to reach a numeric rating scale NRS Pain score ≥4

Secondary Outcome Measures

total pethidine dose received
record total dose of pethidine
mean blood pressure
hemodynamics
heart rate changes
hemodynamics
Incidence of side effects
occurrence of nausea and vomiting

Full Information

First Posted
June 16, 2023
Last Updated
August 22, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05918796
Brief Title
Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia
Official Title
Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ain Shams 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 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
bupivacaine, dexamethasone, quadratus lumborum block

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bupivacaine
Arm Type
Active Comparator
Arm Description
ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally.
Arm Title
bupivacaine and dexamethasone
Arm Type
Active Comparator
Arm Description
ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
dexamethasone
Primary Outcome Measure Information:
Title
measuring the time interval required till the first analgesic dose
Description
to reach a numeric rating scale NRS Pain score ≥4
Time Frame
the first 24 hours
Secondary Outcome Measure Information:
Title
total pethidine dose received
Description
record total dose of pethidine
Time Frame
total pethidine dose received in 24 hours
Title
mean blood pressure
Description
hemodynamics
Time Frame
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.
Title
heart rate changes
Description
hemodynamics
Time Frame
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.
Title
Incidence of side effects
Description
occurrence of nausea and vomiting
Time Frame
record any side effect over 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
rasha g abusinna, MD
Organizational Affiliation
Faculty of medicine Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Hospital
City
Cairo
State/Province
EL Abassia
ZIP/Postal Code
11591
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

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