Clinical trial

Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial

Name

36264PR552/2/24

Description

The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Trial arms

Trial start

2024-03-26

Estimated PCD

2024-08-01

Trial end

2024-08-01

Status

Recruiting

Treatment

Ketamine

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.

Arms:

Ketamine group

Dexmedetomidine

Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.

Arms:

Dex group

Bupivacaine

29 ml bupivacaine 0.25%

Arms:

Dex group, Ketamine group

Size

Primary endpoint

Time to the 1st rescue analgesia

48 hours postoperative.

Eligibility criteria

Inclusion Criteria: * Age ≥ 18 years. * Both sexes. * American Society of Anesthesiology (ASA) physical status I-III. * Scheduled for open thoracotomy. Exclusion Criteria: * Patients with neurological or intellectual disability. * Infection at the injection site. * Opioid addiction. * Allergic reaction to local anesthetics. * Coagulation abnormalities. * Drug abuse. * Pregnancy. * Severe liver and/or renal failure. * Uncontrolled hypertension. * Severe cardiovascular problems. * Diabetes mellitus.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}

Updated at

2024-03-27

1 organization

2 products

1 drug

4 indications

Organization

Tanta University

Drug

Ketamine

Indication

Dexmedetomidine