Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery
NCT07763756 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-08-13
Summary
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.
Conditions
- Breast Cancer
- Postoperative Pain
- Mastectomy
- Regional Anaesthesia
- Intertransverse Process Block
Interventions
- PROCEDURE
-
Multiple Level Intertransverse Process Block
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.
- PROCEDURE
-
Single Level Intertransverse Process Block
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.
Sponsors & Collaborators
-
Antalya City Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-11-01
- Primary Completion
- 2027-06-01
- Completion
- 2027-09-01
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