Analgesic Efficacy of Adding Dexmedetomidine to Erector Spinae Plane Block Versus Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

NCT07075913 | Completed

• 1 other identifier: KFSIRB200-624
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Our scientific work aimed to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant to erector spinae plane block versus subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy.

Conditions

Analgesic Efficacy; Dexmedetomidine; Erector Spinae Plane Block; Subcostal Transverse Abdominis Plane Block; Laparoscopic Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Total dose of morphine consumption

  If the Visual analogue scale (VAS) is ≥ 3, IV morphine was given as a bolus of 2 mg (body weight \< or = 60 kg) or 3 mg (body weight \> 60 kg) with 5 minutes' lockout interval.

  24 hours postoperatively

Secondary Outcomes (7)

• Heart rate

  24 hours postoperatively

• Mean arterial pressure

  24 hours postoperatively

• Intraoperative opioid consumption

  Intraoperatively

• Time to first rescue analgesia

  24 hours postoperatively

• Degree of pain

  24 hours postoperatively

Study Arms (2)

Group I

EXPERIMENTAL

Patients received an ultrasound-guided subcostal transverse abdominis plane block with injection of 10 ml bupivacaine 0.25 %, 5ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Other: Subcostal transverse abdominis plane block

Group II

EXPERIMENTAL

Patients will receive an ultrasound-guided erector spinae plane block (ESPB) with injection of 10 ml bupivacaine 0.25%, 5 ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Other: Erector spinae plane block

Interventions

Subcostal transverse abdominis plane block OTHER

Patients received an ultrasound-guided subcostal transverse abdominis plane block with injection of 10 ml bupivacaine 0.25 %, 5ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Group I

Erector spinae plane block OTHER

Patients will receive an ultrasound-guided erector spinae plane block (ESPB) with injection of 10 ml bupivacaine 0.25%, 5 ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Group II

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age from 20 to 60 years.
• Both sexes.
• American Society of Anesthesiologists (ASA) physical status I and II.
• Patients were planned to undergo laparoscopic cholecystectomy.

You may not qualify if:

• Patient's refusal to participate in the study.
• ASA III, IV.
• History of clinically significant cardiac, hepatic, renal, respiratory or neurological disease.
• Coagulopathy and bleeding disorders.
• Known allergy to any drug included in the study.
• Systemic or local infection at the puncture site.
• Body mass index (BMI) \>35 (kg/m2).
• Failed technique.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

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 Therapy, Faculty of Medicine, Kafr-Elsheikh University, Kafr-Elsheikh, Egypt.

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

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

Locations

EG (1)