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Subtransverse Interligamentary Block Versus Paravertebral Block for Quality of Recovery After Mastectomy

ConditionsQuality of Recovery (QoR-15)Modified Radical Mastectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorTanta University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subtransverse interligamentary plane block (STIL)

    Procedure/Surgery

    Patients will receieve u;trasound guided subtransverse interligamentary plane block

  • Thoracic paravertebral block (TPVB)

    Procedure/Surgery

    Patients will receieve ultrasound guided thoracic paravertebral block

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: subtransverse interligamentary plane blockExperimental treatment 1 intervention
Group B: Thoracic paravertebral blockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative quality of recovery

Postoperative quality of recovery assessed using the Quality of Recovery-15 questionnaire which provides a global score of recovery after anesthesia and surgery by evaluating pain, comfort, emotions, independence, and support. The total score ranges from 0 to 150. Higher score = better recovery.

Time frame
It will be measured 24 hours after surgery

Secondary outcomes

1

Postoperative pain score

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.

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

Time to first rescue analgesia

Time interval from the end of surgery until need of rescue analgesia

Time frame
Postoperatively the time interval from the end of surgery until need of rescue analgesia will be recorded
3

Total postoperative opioid consumption in the first 24 hours

Total postoperative opioid consumption in the first 24 hours will be recorded

Time frame
Total needed postoperative opioid dosing during the first 24 hours will recorded
4

Incidence of postoperative nausea and vomiting

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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