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

Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery, Randomized Double Blinded Comparative Study

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

Study Overview

• Status: Completed
• Conditions: Pain Management; Post Operative Analgesia; Nerve Block/Methods; Erector Spina Plan Block; Local Wound Infiltration
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Local Wound Infiltration

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of fentanyl consumed intraoperatively	Total amount of fentanyl consumed intraoperatively (mic/kg)	Perioperative/Periprocedural
Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.	Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings (beats/min)	Perioperative/Periprocedural
Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings.	Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings (mmHg)	Perioperative/Periprocedural
Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.	Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively (beats/min)	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.	Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively (mmHg)	at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.	The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10cm)	at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Postoperative nausea and vomiting (PONV) as side effects of morphine.	Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe=vomiting >one attack).	up to 24 hours postoperative
Time of first rescue analgesia intra-operative (Fentanyl)	Time of first rescue analgesia (min)	up to 24 hours postoperative
Time of first rescue analgesia post-operative (Morphine)	Time of first rescue analgesia (hrs.)	up to 24 hours postoperative
Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).	Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).	up to 24 hours postoperative
Morphine related complications such as respiratory depression, urine retention or pruritic	Morphine related complications such as respiratory depression, urine retention or pruritic	up to 24 hours postoperative
Patient satisfaction the patient will be classified in this group into satisfied or not.	Patient satisfaction the patient will be classified in this group into satisfied or not.	up to 24 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2024
• Primary Completion (Actual): December 23, 2024
• Study Completion (Actual): December 23, 2024

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Postoperative analgesia; Erector Spinae Plane Block; Local wound infiltration; Breast conservative surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia
• Other Study ID Numbers: MS-433-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No