Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

Post Operative Pain Clinical Trial

Official title:

Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05918796
• Other study ID #: Rasha Gamal Abusinna
• Status: Completed
• Phase: Phase 1
• Start date: June 15, 2023
• Est. completion date: August 1, 2023

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Bupivacaine
18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block
• Dexamethasone
dexamethasone

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo	EL Abassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring the time interval required till the first analgesic dose	to reach a numeric rating scale NRS Pain score =4	the first 24 hours
Secondary	total pethidine dose received	record total dose of pethidine	total pethidine dose received in 24 hours
Secondary	mean blood pressure	hemodynamics	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.
Secondary	heart rate changes	hemodynamics	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.
Secondary	Incidence of side effects	occurrence of nausea and vomiting	record any side effect over 24 hours