Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia

NCT05918796 | Completed Phase 1

• 1 other identifier: Rasha Gamal Abusinna
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

bupivacaine; dexamethasone; quadratus lumborum block

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• total pethidine dose received

  total pethidine dose received in 24 hours

• 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.

• 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.

• Incidence of side effects

  record any side effect over 24 hours

Study Arms (2)

bupivacaine

ACTIVE COMPARATOR

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

Drug: Bupivacaine

bupivacaine and dexamethasone

ACTIVE COMPARATOR

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

Drug: Bupivacaine; Drug: Dexamethasone

Interventions

Bupivacaine DRUG

18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block

bupivacaine; bupivacaine and dexamethasone

Dexamethasone DRUG

dexamethasone

bupivacaine and dexamethasone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, EL Abassia, 11591, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• rasha g abusinna, MD

  Faculty of medicine Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 26, 2023
• Study Start: June 15, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)