Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

NCT ID: NCT05429489

Last Updated: 2024-01-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-27

Study Completion Date

2024-01-10

Brief Summary

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

Detailed Description

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Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Bilevel erector spinae plane block

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

Group Type EXPERIMENTAL

Bilevel erector spinae plane block

Intervention Type PROCEDURE

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

Single level erector spinae plane block

single level erector spinae plane block at 5th thoracic vertebral levels

Group Type EXPERIMENTAL

Single level erector spinae plane block

Intervention Type PROCEDURE

Single level erector spinae plane block at 5th thoracic vertebrae

Intravenous morphine

Intravenous morphine 0.1 mg/ kg

Group Type ACTIVE_COMPARATOR

Intravenous morphine

Intervention Type DRUG

Intravenous morphine 0.1 mg/kg

Interventions

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Bilevel erector spinae plane block

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

Intervention Type PROCEDURE

Single level erector spinae plane block

Single level erector spinae plane block at 5th thoracic vertebrae

Intervention Type PROCEDURE

Intravenous morphine

Intravenous morphine 0.1 mg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female
* Diagnosed with breast cancer

Exclusion Criteria

* Patient refusal
* coagulation defects
* bone metastases
* abnormal kidney and/or liver function tests
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Walaa Youssef Elsabeeny

Assistant professor of Anesthesia and Pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Walaa Y Elsabeeny, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

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Walaa Y Elsabeeny

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AP2205-5015

Identifier Type: -

Identifier Source: org_study_id

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