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Completed

NCT Number: NCT07301840

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

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

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Key information

Conditions

Local Wound Infiltration Agnosia Erector Spina Plan Block Nerve Block/Methods Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Post Operative Analgesia Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Erector Spinae Plane Block

Procedure

Typical ESPB

Local wound infiltration

Procedure

Preemptive Local Wound Infiltration

Primary outcomes

  1. Total amount of morphine consumed postoperatively for 24 hours.

    Time frame: up to 24 hours postoperative

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

Secondary outcomes

  1. Total amount of fentanyl consumed intraoperatively

    Time frame: Perioperative/Periprocedural

    Total amount of fentanyl consumed intraoperatively (mic/kg)

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

    Time frame: Perioperative/Periprocedural

    Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings (beats/min)

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

    Time frame: Perioperative/Periprocedural

    Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings (mmHg)

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

    Time frame: 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)

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

    Time frame: 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)

  6. The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.

    Time frame: 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)

  7. Postoperative nausea and vomiting (PONV) as side effects of morphine.

    Time frame: up to 24 hours postoperative

    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).

  8. Time of first rescue analgesia intra-operative (Fentanyl)

    Time frame: up to 24 hours postoperative

    Time of first rescue analgesia (min)

  9. Time of first rescue analgesia post-operative (Morphine)

    Time frame: up to 24 hours postoperative

    Time of first rescue analgesia (hrs.)

  10. Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).

    Time frame: up to 24 hours postoperative

    Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).

  11. Morphine related complications such as respiratory depression, urine retention or pruritic

    Time frame: up to 24 hours postoperative

    Morphine related complications such as respiratory depression, urine retention or pruritic

  12. Patient satisfaction the patient will be classified in this group into satisfied or not.

    Time frame: up to 24 hours postoperative

    Patient satisfaction the patient will be classified in this group into satisfied or not.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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