Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

• Sponsor: Ain Shams University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05918796
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.5
• Patients Per Site Per Month: 38.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain	Drug: Bupivacaine; Drug: Dexamethasone	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy
• Anticipated Study Start Date: Jun 15, 2023
• Anticipated Primary Completion Date: Aug 1, 2023
• Anticipated Study Completion Date: Aug 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: bupivacaine ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally.	Drug: Bupivacaine; 18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block
Active Comparator: bupivacaine and dexamethasone ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally.	Drug: Bupivacaine; 18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block; Drug: Dexamethasone; dexamethasone

Outcome Measures

Primary Outcome Measures

1. 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

1. total pethidine dose received [total pethidine dose received in 24 hours]

   record total dose of pethidine

2. 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

3. 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

4. Incidence of side effects [record any side effect over 24 hours]

   occurrence of nausea and vomiting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain Shams University Hospital	Cairo	EL Abassia	Egypt	11591

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: rasha g abusinna, MD, Faculty of medicine Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT05918796
• Other Study ID Numbers: Rasha Gamal Abusinna
• First Posted: Jun 26, 2023
• Last Update Posted: Jun 26, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ain Shams University: bupivacaine; dexamethasone; quadratus lumborum block
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone; Bupivacaine

Study Results

No Results Posted as of Jun 26, 2023