Clinical trial

Effect of Adding Dexamethasone to Bupivacaine 0.25% in Superficial Cervical Plexus Block on Surgical Field Visibility During Tympanomastoid Surgery in Adults, A Randomized Controlled Study

Name

MS-426-2023

Description

The aim of this study is to evaluate the efficacy of adding dexamethasone to bupivacaine 0.25% in ultrasound-guided SCPB on surgical field visibility during tympanomastoid surgery.

Trial arms

Trial start

2024-05-15

Estimated PCD

2024-06-30

Trial end

2024-07-15

Status

Not yet recruiting

Phase

Early phase I

Treatment

bupivacaine 0.25%

SCPB using 10 ml of bupivacaine 0.25%

Arms:

Bupivacaine

dexamethasone 2 mg in bupivacaine 0.25%

SCPB using dexamethasone 2 mg in 10 ml of bupivacaine 0.25%

Arms:

Bupivacaine plus dexamethasone

Size

Primary endpoint

Modena bleeding score

up to 5 hours

Eligibility criteria

Inclusion Criteria: 1. ASA I \& ASA II patients 2. Patients undergoing tympanomastoid surgery. 3. Age group: from 21 to 70 years old. 4. Duration of surgery less than 5 hours. Exclusion Criteria: * Patient refusal. * Uncooperative patients. * Allergy to local anesthetics or dexamethasone. * Anatomical abnormalities include malformations, deformities, growths, or structural irregularities. * Infection at injection site. * Coagulopathy: PTT \> 40 seconds, INR \> 1.4, platelet count \< 100x10⁹. or drug induced bleeding disorders

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

Updated at

2024-05-17

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product