Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07367568

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

This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.

Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.

A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult females > 18 years and ≤ 65 years old.
  • American Society of Anesthesiologists (ASA) physical status П-III.
  • Body mass index (BMI) 18-35 kg/m2.
  • Scheduled for modified radical mastectomy.

Exclusion criteria

  • Known allergy or hypersensitivity to local anesthetic agents.
  • Active infection at the injection site (e.g., cellulitis, abscess).
  • Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].
  • Severe respiratory, cardiac, hepatic, or renal disease.
  • Morbid obesity.
  • Severe cognitive impairment or uncooperative behavior that could interfere with block placement.

Treatment and study plan

Costotransverse foramen block

Other

Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.

Erector spinae plane block

Other

Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.

Secondary outcomes

  1. Degree of pain

    Time frame: 48 hours postoperatively

    Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.

  2. Time to first request of rescue analgesia

    Time frame: 24 hours postoperatively

    Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.

  3. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    Intraoperative fentanyl consumption will be recorded.

  4. Mean arterial pressure

    Time frame: 4 hours postoperatively

    Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.

  5. Heart rate

    Time frame: 4 hours postoperatively

    Heart rate will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.

  6. Incidence of adverse effects

    Time frame: 24 hours postoperatively

    Incidence of adverse effects such as nausea, vomiting, hypotension, and bradycardia, pneumothorax, local anesthetic toxicity for up to 24 hours post-surgery will be documented.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai M Elrawas, MD

CONTACT

[email protected]

00201222177242

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 27, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

Published trials that share one or more normalized conditions with this study.