Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

NCT06825286 | Completed

• 1 other identifier: 36264MS296/8/23
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.

Conditions

Dexmedetomidine; Bupivacaine; Ultrasound-Guided; Quadratus Lumborum Block; Postoperative Analgesia; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia

  24 hours postoperatively

Secondary Outcomes (6)

• Mean arterial blood pressure

  At the end of the operation(Up to 48 min).

• Heart rate

  At the end of the operation (Up to 48 min).

• lntraoperative fentanyl consumption

  lntraoperatively

• Degree of pain score

  24 hours postoperatively

• Time to the first request for the rescue analgesia

  24 hours postoperatively

Study Arms (2)

Bupivacaine group

ACTIVE COMPARATOR

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20 ml bupivacaine 0.25%)

Drug: Bupivacaine

Bupivacaine and Dexmedetomidinc group

EXPERIMENTAL

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine I mic/kg)

Drug: Bupivacaine and Dexmedetomidinc) group

Interventions

Bupivacaine DRUG

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block wilh (20 ml bupivacaine 0.25%).

Bupivacaine group

Bupivacaine and Dexmedetomidinc) group DRUG

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine Imic/kg)

Bupivacaine and Dexmedetomidinc group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 21-65 years.
• Both genders.
• American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy

You may not qualify if:

• Patient refusal
• History of allergy to local anesthetic.
• Liver or renal pathology affecting drug elimination
• Menta!dysfunction or cognitive disorders.
• Patients on chronic pain medications.
• Body Mass Index \> 40 kg/m2.
• Coagulopathy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, ElGharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Population Groups

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine,Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: February 8, 2025
• First Posted: February 13, 2025
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data was available upon a reasonable request from the corresponding author.

Locations

EG (1)