Ultrasound Guided Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy

NCT07647367 | Not Yet Recruiting DMC

• 1 other identifier: 36265PR77/5/26
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled double blinded non-inferiority study will be carried out in Tanta University Hospitals for duration of 6 months from June 2026 to December 2026 on 60 female patients scheduled for unilatral modified radical mastectomy under general anesthesia.

Conditions

Quality of Recovery After Modified Radical Mastectomy

Keywords

subtransverse interligamentary plane block; modified radical mastectomy; quality of recovery

Outcome Measures

Primary Outcomes (1)

• Postoperative quality of recovery

  Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire 24 hours after surgery

  It will be measured 24 hours after surgery

Secondary Outcomes (6)

• Postoperative pain score

  It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively

• Time to first rescue analgesia

  Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded

• Total postoperative opioid consumption in the first 24 hours

  Total needed postoperative opioid dosing during the first 24 hours will recorded

• Incidence of postoperative nausea and vomiting

  Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours

• The degree of patient satisfaction

  it will be recorded postoperatively and 24 hours after surgery

Study Arms (2)

subtransverse interligamentary plane block

EXPERIMENTAL

Patients will receive ultrasound-guided subtransverse interligamentary plane block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))

Procedure: Subtransverse interligamentary plane block (STIL)

Thoracic paravertebral block

ACTIVE COMPARATOR

Patients will receive ultrasound- guided thoracic paravertebral block with local anesthetic mixture (20 mL 0.25% bupivacaine, 100 micrograms of fentanyl (2ml))

Procedure: Thoracic paravertebral block (TPVB)

Interventions

Subtransverse interligamentary plane block (STIL) PROCEDURE

Patients will receieve u;trasound guided subtransverse interligamentary plane block

Also known as: Arm 1

subtransverse interligamentary plane block

Thoracic paravertebral block (TPVB) PROCEDURE

Patients will receieve ultrasound guided thoracic paravertebral block

Thoracic paravertebral block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only participants who self identity as women are eligible to participate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female patients aged 18 to 65 years with American Society of Anesthesiologists (ASA) Physical Status I - III, who were scheduled for unilateral MRM surgery under general anesthesia and able to understand and complete the QoR-15 questionnaire

You may not qualify if:

• Patients declined to participate in the trial.
• History of allergy to the used local anesthetic (LA) drugs.
• Patients with cutaneous lesions at the needle entry point.
• Coagulopathy or current anticoagulant therapy contraindicating regional block.
• Patients with severe hepatic, renal, cardiac, or respiratory disease.
• Psychiatric or cognitive disorder interfering with QoR-15 assessment
• Chronic opioid use or chronic pain syndrome.
• Failed block.
• Morbid obesity (body mass index \>40 kg/m2)
• Intraoperative major complications requiring postoperative ICU admission.
• Pregnancy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta university hospital

Tanta, 31527, Egypt

Location

Related Publications (6)

• Arun N, Singh R, Kumar M. Direct Pectoral Nerve Block versus Ultrasound-Guided Paravertebral Block for Analgesia and Improved Recovery after Modified Radical Mastectomy: A Randomized Clinical Trial. Sri Lankan Journal of Anaesthesiology. 2026;34(1).

  RESULT

• Ince I, Dostbil A, Ozmen O, Aksoy M, Karadeniz E. Subtransverse process interligamentary (STIL) plane block for postoperative pain management after breast surgery. J Clin Anesth. 2020 May;61:109649. doi: 10.1016/j.jclinane.2019.109649. Epub 2019 Nov 17. No abstract available.

  PMID: 31744747 RESULT

• Kilicaslan A, Sarkilar G, Altinok T, Tulgar S. A novel ultrasound-guided technique in peri-paravertebral area: Subtransverse process interligamentary (STIL) plane block: The game has not ended yet. J Clin Anesth. 2020 Mar;60:76-77. doi: 10.1016/j.jclinane.2019.08.047. Epub 2019 Aug 30. No abstract available.

  PMID: 31476624 RESULT

• Ardon AE, Lee J, Franco CD, Riutort KT, Greengrass RA. Paravertebral block: anatomy and relevant safety issues. Korean J Anesthesiol. 2020 Oct;73(5):394-400. doi: 10.4097/kja.20065. Epub 2020 Mar 16.

  PMID: 32172551 RESULT

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.

  PMID: 31280100 RESULT

• Ferlay J, Colombet M, Soerjomataram I, Parkin DM, Pineros M, Znaor A, Bray F. Cancer statistics for the year 2020: An overview. Int J Cancer. 2021 Apr 5. doi: 10.1002/ijc.33588. Online ahead of print.

  PMID: 33818764 RESULT

Central Study Contacts

Mai Salah Salem, MD anesthesia, SIC

CONTACT

01061107658; mai.salah@med.tanta.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: lecturer of anesthesia, SIC and pain medicine

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year

Locations

EG (1)