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

June 9, 2026 updated by: Mai Salah Salem, Tanta University

Ultrasound-Guided Subtransverse Interligamentary Plane Block Versus Thoracic Paravertebral Block for Quality of Recovery After Modified Radical Mastectomy: A Randomized Non-Inferiority Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast carcinoma is a common malignancy in females, with modified radical mastectomy (MRM) being the most frequently performed surgery. Surgical intervention is accompanied by significant challenges such as postoperative pain and stress, potentially leading to prolonged hospitalizations and complications. Previous studies had demonstrated that thoracic paravertebral block (TPVB) was effective in diminishing opioid requirements for patients undergoing breast surgery. TPVB is technically challenging, requiring skilled healthcare professionals and the narrow paravertebral space, located between the superior costotransverse ligament (SCTL) and the parietal pleura, poses a risk of inadvertent pleural puncture and vascular damage, and increased the potential for pneumothorax and haematoma. The Subtransverse process Interligamentary (STIL) plane block is a recently introduced technique that holds promise as an alternative to TPVB. STIL plane block specifically targets the region adjacent to the paravertebral space, rather than directly penetrating it, which theoretically diminishes the potential risks of inadvertent pneumothorax and hematoma compared with TPVB. Additionally, due to its close anatomical proximity to the paravertebral space, the STIL plane block may facilitate a more straightforward dispersion of local anaesthetics into this area. Research has also confirmed that the block achieved with STIL plane block is effective in providing adequate pain relief for breast surgeries. Also it was associated with decreased postoperative opioid consumption compared to the ESP block in patients undergoing MRM. With the improvement of anaesthesia technology, the quality of patient recovery is no longer solely measured by the success of the surgery or the discharge rate, but is increasingly oriented towards a "patient-centered" approach that focuses on the safety, comfort, and overall quality of recovery throughout the perioperative period. In light of the growing emphasis on improving postoperative quality of recovery while ensuring patient safety, we hypothesize that the STIL plane block will demonstrate non-inferiority to the thoracic PVB in terms of postoperative quality of recovery and analgesia in patients undergoing MRM.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Tanta, Egypt, 31527
        • Tanta university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subtransverse interligamentary plane block
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)
Patients will receieve u;trasound guided subtransverse interligamentary plane block
Other Names:
  • Arm 1
Active Comparator: Thoracic paravertebral block
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)
Patients will receieve ultrasound guided thoracic paravertebral block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative quality of recovery
Time Frame: It will be measured 24 hours after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain score
Time Frame: It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively
Postoperative pain score using numerical rating scale (NRS) score The NRS is an 11-point pain scale ranging from 0 to 10, where 0 means no pain and 10 means the worst imaginable pain. Participants are asked to rate their pain intensity by choosing the number that best represents their pain level.
It will be measured at rest and during arm movement at 0,2,6,12,24 hours postoperatively
Time to first rescue analgesia
Time Frame: Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded
Time interval from the end of surgery until need of 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
Time Frame: Total needed postoperative opioid dosing during the first 24 hours will recorded
Total postoperative opioid consumption in the first 24 hours will be recorded
Total needed postoperative opioid dosing during the first 24 hours will recorded
Incidence of postoperative nausea and vomiting
Time Frame: Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
Postoperative incidence of postoperative nausea and vomiting will be recorded during the first 24 hours
The degree of patient satisfaction
Time Frame: it will be recorded postoperatively and 24 hours after surgery
The degree of patient satisfaction using level of satisfaction regarding the analgesia regimen using a 5 point Likert scale, where 1 indicates "extremely dissatisfied", 2 "unsatisfied", 3 "unsure", 4 "satisfied", and 5 "extremely satisfied"
it will be recorded postoperatively and 24 hours after surgery
Block performance time
Time Frame: Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection
Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection will be recorded
Block performance time from the start of space visualization by ultrasound until the end of local anesthetic injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 36265PR77/5/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author

IPD Sharing Time Frame

The data will be available upon a reasonable request from the corresponding author after the end of the study for 1 year

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Recovery After Modified Radical Mastectomy

Clinical Trials on Subtransverse interligamentary plane block (STIL)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe