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

NCT07367568 | Recruiting

• 1 other identifier: AP2509-501-124-203
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Costotransverse Foramen Block; Erector Spinae Plane Block; Modified Radical Mastectomy

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  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.

  24 hours postoperatively

Secondary Outcomes (6)

• Degree of pain

  48 hours postoperatively

• Time to first request of rescue analgesia

  24 hours postoperatively

• Intraoperative fentanyl consumption

  Intraoperatively

• Mean arterial pressure

  4 hours postoperatively

• Heart rate

  4 hours postoperatively

Study Arms (2)

CTFB Group

EXPERIMENTAL

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

Other: Costotransverse foramen block

ESPB Group

EXPERIMENTAL

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

Other: Erector spinae plane block

Interventions

Costotransverse foramen block OTHER

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

CTFB Group

Erector spinae plane block OTHER

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

ESPB Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Females scheduled for modified radical mastectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Cairo University

Cairo, 12613, Egypt

RECRUITING

Central Study Contacts

Mai M Elrawas, MD

CONTACT

00201222177242; mai.elrawas@nci.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: January 24, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)