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Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

A

Ain Shams University

Status and phase

Completed
Phase 1

Conditions

Post Operative Pain

Treatments

Drug: Dexamethasone
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05918796
Rasha Gamal Abusinna

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

bupivacaine
Active Comparator group
Description:
ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally.
Treatment:
Drug: Bupivacaine
bupivacaine and dexamethasone
Active Comparator group
Description:
ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.
Treatment:
Drug: Bupivacaine
Drug: Dexamethasone

Trial contacts and locations

1

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Central trial contact

rasha g abusinna, MD

Data sourced from clinicaltrials.gov

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