Clinical trial

Analgesic Efficacy of Different Volumes in Erector Spinae Plane Block in Patients Undergoing Single Level Lumbar Spine Fixation: A Non-inferiority Randomized Clinical Trial

NCT05892887

Name

MKSU 50- 1 - 10

Description

The analgesic efficacy of different volumes in ESPB patients undergoing single-level lumbar spine fixation

Trial arms

Trial start

2023-06-01

Estimated PCD

2023-09-20

Trial end

2023-09-20

Status

Completed

Phase

Early phase I

Treatment

Bupivacaine 0.25% Injectable Solution

Bilateral ultrasound guided in erector spinae plane block by bupivacaine 0.25%

Arms:

Erector 10, Erector 15, Erector 20

Size

Primary endpoint

Total morphine consumption

First 24 hours postoperatively

Eligibility criteria

Inclusion Criteria: 1. Aged 18-65 years. 2. Both genders. 3. American Society of Anesthesiologists' (ASA) physical status I or II. 4. Undergoing single level lumbar spine fixation. Exclusion Criteria: 1. Patient refusal. 2. Pregnant females. 3. Renal, lung, heart, or liver disorders. 4. Communication difficulties which might prevent a reliable postoperative assessment. 5. Contraindication to regional anesthesia (bleeding disorder, use of any anticoagulants, local infection, known allergy to local anesthetics). 6. BMI more than 30 kg/m2.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-10-10

1 organization

1 product

1 indication

Organization

Kafrelsheikh University

Product

Bupivacaine

Indication

Analgesic