About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18-65 years
ASA physical status I-III
Scheduled for elective breast cancer surgery
Body mass index (BMI) between 18 and 35 kg/m²
Disqualifiers
Refusal to participate
Allergy to local anesthetics
Infection at the injection site
Coagulopathy or ongoing anticoagulant therapy
Trial design
Parallel
Treatments tested in this trial
Multiple Level Intertransverse Process Block
Procedure/SurgeryUsing 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/SurgeryUsing 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.
Treatment groups
Trial outcomes
Primary outcomes
postoperative pain intensity (VAS score)
Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.
Secondary outcomes
Total opioid consumption via patient-controlled analgesia (PCA)
Requirement for rescue analgesia
Block performance time
Block-related and systemic side effects
Locations
Sponsors and contacts
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