TPVB, PECSB, ESPB for Postmastectmy Pain

Overview

Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.

Full Title of Study: “A Comparative Study Between Ultrasound-guided Thoracic Paravertebral Block, Pectoral Nerves Block, and Erector Spinae Block for Pain Management in Cancer Breast Surgeries. A Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 10, 2021

Interventions

  • Procedure: Ultrasound guided block
    • Giving one regional block
  • Drug: IV morphine
    • given when VAS>3

Arms, Groups and Cohorts

  • Placebo Comparator: Control Group (D)
    • Patient will receive opioid only for management of their perioperative pain
  • Active Comparator: Paravertebral block Group (A)
    • Will receive thoracic paravertebral block
  • Active Comparator: Pectoral block Group (B)
    • Will receive pectoral 1 and 2 block
  • Active Comparator: Erector spinae block Group (C)
    • Will receive erector spinae block

Clinical Trial Outcome Measures

Primary Measures

  • The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).
    • Time Frame: 0-24o minutess
    • minutes

Secondary Measures

  • Postoperative pain
    • Time Frame: 48 hours
    • assessed by VAS score (0-10) where 0=no pain and 10=worst pain
  • Total morphine consumption
    • Time Frame: 48 hours
    • recorded postoperatively in mg
  • Postoperative nausea and vomiting (PONV)
    • Time Frame: 48 hours
    • 4 points score of PONV (0-3) where 0=no PONV and 3=vomiting more than once

Participating in This Clinical Trial

Inclusion Criteria

1. ASA physical status classification class I or II 2. Age group 18 – 60 years of the female gender 3. Patients undergoing breast cancer surgeries Exclusion Criteria:

1. Patient refusal 2. History of hypersensitivity to local anesthetics 3. Bleeding disorders or patients receiving anticoagulants 4. Spine or chest wall deformities 5. Pregnancy 6. Local infection at the site of injection.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Menoufia University
  • Provider of Information About this Clinical Study
    • Principal Investigator: kareem Mikhamer, Assistant fellow – Menoufia University
  • Overall Official(s)
    • kareem M mikhimer, m.sc, Principal Investigator, assistant fellow, Ahmed Maher Hospital

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