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Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery

Cairo University (CU) logo

Cairo University (CU)

Status

Completed

Conditions

Post Operative Analgesia
Pain Management
Nerve Block/Methods
Local Wound Infiltration
Erector Spina Plan Block

Treatments

Procedure: Local Wound Infiltration
Procedure: Erector Spinae Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT07301840
MS-433-2024

Details and patient eligibility

About

Abstract

Background:

Postoperative pain management is a crucial component of patient care following breast conservative surgery. This study compares the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Local Wound Infiltration (LWI) in managing acute postoperative pain in these surgeries.

Objectives:

This randomized, double-blinded, controlled clinical trial aims to compare the analgesic efficacy and safety of ultrasound-guided ESPB and LWI in patients undergoing breast conservative surgery.

Patients and methods:

Adult female patients (aged 18-75, ASA II) scheduled for breast conservative surgery were randomly assigned to either the ESPB or LWI group. The primary outcome was total morphine consumption in the first 24 hours postoperatively. Secondary outcomes included; intraoperative fentanyl consumption, hemodynamic parameters (mean arterial blood pressure and heart rate), time of first rescue analgesia, postoperative pain scores, the incidence of postoperative nausea and vomiting (PONV) and patient satisfaction. Complications such as local anesthetic toxicity and respiratory depression were also assessed.

Key Words:

Erector Spinae Plane Block (ESPB), Local wound infiltration, Postoperative analgesia, Breast conservative surgery

Enrollment

66 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age from 18 to 75 years.
  • Genders eligible for study: females.
  • ASA II.
  • Patients scheduled for breast conservative surgery.
  • Ability to provide informed consent or, if unable, consent obtained from a legal representative

Exclusion criteria

  • Patient refusal.
  • Inability to provide informed consent.
  • ASA III-IV.
  • Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
  • Pregnant or lactating women.
  • History of psychological disorders and/or chronic pain. 25
  • Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
  • Severe respiratory or cardiac disorders.
  • Advanced liver or kidney disease.
  • Male patients.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

Group 1 (experimental group): will receive US guided ESPB
Experimental group
Treatment:
Procedure: Erector Spinae Plane Block
Group 2 (controlled group): will receive local wound infiltration
Active Comparator group
Treatment:
Procedure: Local Wound Infiltration

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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