Clinical trial

Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

Name

AP2205-5015

Description

This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries

Trial arms

Trial start

2022-06-27

Estimated PCD

2023-12-27

Trial end

2024-01-10

Status

Completed

Treatment

Bilevel erector spinae plane block

Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels

Arms:

Bilevel erector spinae plane block

Single level erector spinae plane block

Single level erector spinae plane block at 5th thoracic vertebrae

Arms:

Single level erector spinae plane block

Intravenous morphine

Intravenous morphine 0.1 mg/kg

Arms:

Intravenous morphine

Size

126

Primary endpoint

Total analgesic requisite

First 24 hours postoperatively

Eligibility criteria

Inclusion Criteria: * Female * Diagnosed with breast cancer Exclusion Criteria: * Patient refusal * coagulation defects * bone metastases * abnormal kidney and/or liver function tests

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}

Updated at

2024-01-23

1 organization

1 product

1 indication

Organization

National Cancer Institute, Egypt

Product

Morphine

Indication

Analgesic