Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

Phase 1

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Bupivacaine; Drug: Dexamethasone

• Registration Number: NCT05918796
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-15
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-06-26
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine	Bupivacaine	ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally.
bupivacaine and dexamethasone	Bupivacaine	ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.
bupivacaine and dexamethasone	Dexamethasone	ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.

Primary Outcome Measures

Name	Time	Method
measuring the time interval required till the first analgesic dose	the first 24 hours	to reach a numeric rating scale NRS Pain score ≥4

Secondary Outcome Measures

Name	Time	Method
total pethidine dose received	total pethidine dose received in 24 hours	record total dose of pethidine
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.	hemodynamics
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.	hemodynamics
Incidence of side effects	record any side effect over 24 hours	occurrence of nausea and vomiting

Trial Locations

Locations (1)

Ain Shams University Hospital; 🇪🇬 Cairo, EL Abassia, Egypt