Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

January 20, 2024 updated by: Walaa Youssef Elsabeeny, National Cancer Institute, Egypt

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11796
        • Walaa Y Elsabeeny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female
  • Diagnosed with breast cancer

Exclusion Criteria:

  • Patient refusal
  • coagulation defects
  • bone metastases
  • abnormal kidney and/or liver function tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilevel erector spinae plane block
Bilevel erector spinae block at 3rd and 5th thoracic vertebral levels
Procedure: Bilevel erector spinae plane block
Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels
Experimental: Single level erector spinae plane block
single level erector spinae plane block at 5th thoracic vertebral levels
Procedure: Single level erector spinae plane block
Single level erector spinae plane block at 5th thoracic vertebrae
Active Comparator: Intravenous morphine
Intravenous morphine 0.1 mg/ kg
Drug: Intravenous morphine
Intravenous morphine 0.1 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total analgesic requisite
Time Frame: First 24 hours postoperatively
total postoperative morphine consumption
First 24 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute, Egypt

Investigators

  • Principal Investigator: Walaa Y Elsabeeny, MD, National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2022

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

June 17, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP2205-5015

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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