Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries

Overview

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

Full Title of Study: “Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 30, 2023

Interventions

  • Procedure: Bilevel erector spinae plane block
    • Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels
  • Procedure: Single level erector spinae plane block
    • Single level erector spinae plane block at 5th thoracic vertebrae
  • Drug: Intravenous morphine
    • Intravenous morphine 0.1 mg/kg

Arms, Groups and Cohorts

  • Experimental: Bilevel erector spinae plane block
    • Bilevel erector spinae 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
  • Active Comparator: Intravenous morphine
    • Intravenous morphine 0.1 mg/ kg

Clinical Trial Outcome Measures

Primary Measures

  • Total analgesic requisite
    • Time Frame: First 24 hours postoperatively
    • total postoperative morphine consumption

Participating in This Clinical Trial

Inclusion Criteria

  • Female – Diagnosed with breast cancer Exclusion Criteria:

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

Gender Eligibility: Female

Females

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Cancer Institute, Egypt
  • Provider of Information About this Clinical Study
    • Principal Investigator: Walaa Youssef Elsabeeny, Assistant professor of Anesthesia and Pain management – National Cancer Institute, Egypt
  • Overall Official(s)
    • Walaa Y Elsabeeny, MD, Principal Investigator, National Cancer Institute (NCI)
  • Overall Contact(s)
    • Walaa Y Elsabeeny, MD, +201007798466, walaa.elsabeeny@nci.cu.edu.eg

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