Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
FEMALE
ID07367568

Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial

Led by National Cancer Institute, Egypt · Updated on 2026-01-27

110

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial evaluates two types of nerve blocks, the costotransverse foramen block and the erector spinae plane block, in adult women undergoing modified radical mastectomy, a surgery often followed by significant pain affecting the upper limbs, axillae, and chest area. The study compares how these blocks may help reduce the need for pain medication after surgery. Both nerve blocks aim to provide pain relief by targeting nerves in the thoracic region but differ in technique and anesthetic distribution. Participants will be randomly assigned to receive either an ultrasound-guided costotransverse foramen block or erector spinae plane block on the same side as the surgery. Each block involves injecting 20 ml of 0.25% bupivacaine, a local anesthetic, to manage postoperative pain. These procedures are performed before surgery to help control pain afterward. During the study, researchers will monitor morphine use in the first 24 hours after surgery as the main outcome. They will also assess pain levels for up to 48 hours, track the time until the first request for additional pain relief, and record intraoperative fentanyl use. Heart rate, blood pressure, and any side effects will be observed during and after surgery to evaluate safety and effectiveness. Participants will be followed closely during the immediate postoperative period to gather these data.

CONDITIONS

Brief Title

Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female adults older than 18 years and up to 65 years old
  • American Society of Anesthesiologists (ASA) physical status classification I to III
  • Body mass index between 18 and 35 kg/m2
  • Scheduled for modified radical mastectomy
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to local anesthetic agents
  • Active infection at the injection site such as cellulitis or abscess
  • Blood clotting disorders or current use of anticoagulant or antiplatelet medication with INR above 1.5 or platelet count below 100,000/µL
  • Severe diseases affecting lungs, heart, liver, or kidneys
  • Morbid obesity
  • Severe cognitive impairment or uncooperative behavior that may interfere with block placement

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of surgery

Participants receive one of two types of ultrasound-guided nerve blocks during modified radical mastectomy to manage postoperative pain.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - 48 hours postoperatively

Participants are monitored for pain levels, analgesic use, vital signs, and adverse effects after surgery.

Approximately 2 visits within 48 hours post-surgery

Trial Site Locations

Total: 1 location

1

Cairo University

Cairo, Egypt, 12613

Actively Recruiting

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Research Team

M

Mai M Elrawas, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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