Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery
NCT ID: NCT07301840
Last Updated: 2025-12-24
Study Results
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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COMPLETED
NA
66 participants
INTERVENTIONAL
2024-08-21
2024-12-23
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1 (experimental group): will receive US guided ESPB
Erector Spinae Plane Block
Typical ESPB
Group 2 (controlled group): will receive local wound infiltration
Local Wound Infiltration
Preemptive Local Wound Infiltration
Interventions
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Erector Spinae Plane Block
Typical ESPB
Local Wound Infiltration
Preemptive Local Wound Infiltration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Tasneem Hassan El-Tohamy
Dr
Locations
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National Cancer Institute
Cairo, , Egypt
Countries
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Other Identifiers
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MS-433-2024
Identifier Type: -
Identifier Source: org_study_id