Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery

Sponsor
Antalya City Hospital
Study ID
NCT07763756
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer
  • Intertransverse Process Block
  • Mastectomy
  • Postoperative Pain
  • Regional Anaesthesia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Multiple Level Intertransverse Process Block — PROCEDURE
    Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be advanced from lateral to medial, with the needle tip positioned immediately posterior to the SCTL at each intertransverse level. Proper needle placement will be confirmed by injection of 1-2 mL isotonic saline and sonographic visualization of appropriate injectate spread and anterior displacement of the pleura. Upon confirmation and negative aspiration, 5 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered at each of the T2-T3, T3-T4, T4-T5, and T5-T6 levels, resulting in a total volume of 20 mL.
  • Single Level Intertransverse Process Block — PROCEDURE
    Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be advanced from lateral to medial, with the needle tip positioned immediately posterior to the SCTL at the T4-T5 intertransverse level. Proper needle placement will be confirmed by injection of 1-2 mL isotonic saline and sonographic visualization of appropriate injectate spread and anterior displacement of the pleura. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered.

Study Details

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of single Intertransverse Process Block (ITP) and multiple Intertransverse Process Block (ITP) in patients undergoing Breast Cancer Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.

Key Dates

First listed
Aug 13, 2026
Start date
Nov 1, 2026
Status verified
Aug 2026
Primary completion
Jun 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Single Level Intertransverse Process Block
  • Active Comparator: Multiple Level Intertransverse Process Block

Primary Outcome Measure

postoperative pain intensity (VAS score) [ Time Frame: 0, 1, 4, 8, 12, and 24 hours after surgery ]

Central Contacts

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