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

NCT ID: NCT07075913

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Laparoscopic cholecystectomy (LC) is the most commonly performed surgical procedure for the management of cholelithiasis. Acute pain after LC consists of somatic, parietal, and referred pain caused by trocar insertion, gall bladder resection, carbon dioxide insufflation, and other factors.

The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin.

Ultrasound-guided erector spinae plane block (ESPB) is a popular, interfascial regional technique initially described for managing thoracic neuropathic pain.

Dexmedetomidine is an alpha-2 adrenergic receptor agonist that has been the focus of interest due to its sedative, analgesic, perioperative sympatholytic, and cardiovascular-stabilizing effects, resulting in reduced anesthetic requirements.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I

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 Type EXPERIMENTAL

Subcostal transverse abdominis plane block

Intervention Type 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 II

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 Type EXPERIMENTAL

Erector spinae plane block

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Subcostal transverse abdominis plane block

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.

Intervention Type OTHER

Erector spinae plane block

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kafrelsheikh University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lamees Elsayed Ali Soliman Shaloof

Resident of Anesthesia, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Kafr-Elsheikh University, Kafr-Elsheikh, Egypt.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KFSIRB200-624

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dexamethasone-Enhanced TAP Block in Lapchole
NCT07182110 ACTIVE_NOT_RECRUITING PHASE1