Erector Spinae Plane Block Versus Local Wound Infiltration After Modified Radical Mastectomy

NCT06533566 | Completed DMC

• 1 other identifier: pain after mastectomy
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.

Conditions

Post Operative Pain; Erector Spinae Plane Block; Local Infiltration

Outcome Measures

Primary Outcomes (1)

• total morphine consumption

  total morphine amount which will be consumed in the first postoperative day

  first postoperative day after modified radical mastectomy surgery

Study Arms (2)

Erector Spinae Block

ACTIVE COMPARATOR

Patients of this group will receive ultrasound guided erector spinae block with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected beneath the erector spinae muscle sheath at the level of the fourth transvers process (T4).

Procedure: Erector spinae plane block

Drain block

ACTIVE COMPARATOR

Patients of this group will receive local wound infiltration (drain block) with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected in each surgical drain (pectoral and axillary drains) thereafter, the drains would then clamped for 20 minutes and declamped later on.

Procedure: local wound infiltration

Interventions

Erector spinae plane block PROCEDURE

patients will be placed in the lateral decubitus position. The ESP block is usually performed at the level of fourth transvers process. The ultrasound probe should be placed in a cephalo-caudal orientation over the midline of the back at the desired level.Under aseptic conditions, the block needle will be inserted in plane at an angle of 30-40° in cranial-to-caudal direction until the tip contacted the T4 transverse process at erector spinae plane. After hydro-dissection with 2-3 mL of isotonic saline solution to confirm the correct needle tip position and after negative aspiration to prevent intra vascular injection or position, (20 ml) of plain bupivacaine 0.25% will be injected deep to the erector spinae muscle.

Erector Spinae Block

local wound infiltration PROCEDURE

after the surgeon complete the surgery and insert the surgical drains (pectoral and axillary drains) we will inject 20ml of plain bupivacaine 0.25% in each surgical drain, the drains will be clamped for 20 minutes then declamped.

Also known as: drain block

Drain block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiology (ASA) physical status I-II
• scheduled for unilateral Modified radical mastectomy

You may not qualify if:

• Patient refusal.
• Patient with neurological deficit.
• Patient with bleeding disorders.
• Uncooperative patient.
• Infection at the block injection site.
• Patients with history of allergy to local anesthetics.
• Advanced hepatic, cardiac or renal failure.
• Chronic opioid consumption.
• Body mass index (BMI)≥ 30 kg m-2
• Chronic use of gabapentin or pregabalin

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of medicine, Tanta university

Tanta, El Gharbyia, 31111, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 10, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)