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

NCT07301840 | Completed

• 1 other identifier: MS-433-2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Erector Spinae Plane Block; Local wound infiltration; Postoperative analgesia; Breast conservative surgery

Outcome Measures

Primary Outcomes (1)

• Total amount of morphine consumed postoperatively for 24 hours.

  Total amount of morphine consumed postoperatively for 24 hours (mg/kg)

  up to 24 hours postoperative

Secondary Outcomes (12)

• Total amount of fentanyl consumed intraoperatively

  Perioperative/Periprocedural

• Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.

  Perioperative/Periprocedural

• Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings.

  Perioperative/Periprocedural

• Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

• Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

Study Arms (2)

Group 1 (experimental group): will receive US guided ESPB

EXPERIMENTAL

Procedure: Erector Spinae Plane Block

Group 2 (controlled group): will receive local wound infiltration

ACTIVE COMPARATOR

Procedure: Local Wound Infiltration

Interventions

Erector Spinae Plane Block PROCEDURE

Typical ESPB

Group 1 (experimental group): will receive US guided ESPB

Local Wound Infiltration PROCEDURE

Preemptive Local Wound Infiltration

Group 2 (controlled group): will receive local wound infiltration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Randomized Double Blinded Comparative Study

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 24, 2025
• Study Start: August 21, 2024
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)