Dexmetomidine With Erector Spinae Plane Block in Cholecystectomy

NCT05369468 | Completed Phase 1 DMC

• 1 other identifier: 35225/1/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Sixty patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned using sealed envelope into two equal groups (30 patients each). Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection . Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .

Conditions

Dexmedtomidine in Erector Spinae Block for Laparscopic Cholecystectomy

Keywords

dexmedtomidine-erector spinae block-cholecystectomy

Outcome Measures

Primary Outcomes (1)

• postoperative morphine consumption

  the total amount of morphine consumption in the first 24-hour postoperative

  first 24 hours

Study Arms (2)

group 1

PLACEBO COMPARATOR

Group 1: will receive bilateral ESP block with injection of 20 ml of 0.25% Bupivacaine in each site of injection .

Drug: Bupivacain only

group 2

EXPERIMENTAL

Group 2: will receive bilateral ESP block with injection of 18ml of 0.25% Bupivacaine plus 2ml dexmedetomidine 0.5 ug /kg in each site of injection .

Drug: dexmedetomidine as adjuvant with bupivacaine

Interventions

dexmedetomidine as adjuvant with bupivacaine DRUG

to assess efficacy of adding dexmedetomidine as adjuvant with bupivacaine in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.

group 2

Bupivacain only DRUG

to assess efficacy of bupivacain alone in ultrasound-guided erector spinae plane block in patient undergoing laporoscopic cholecystectomy. primary outcome was the total amount of morphine consumption in the first 24-hour postoperative, and the secondary outcomes were the time of first rescue analgesia ,pain score, and safety.

group 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• patients who refuse to give written informed consent
• sever respiratory or cardiac disorder
• coagulopathy
• local infection at injection site
• spine or chest wall deformity
• patients with known allergy to the drugs used

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Adjuvants, Pharmaceutic; Bupivacaine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: both investigator and outcome assessor do not know in which group is the patient
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 11, 2022
• Study Start: January 22, 2020
• Primary Completion: November 10, 2022
• Study Completion: November 10, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)