Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorAntalya City Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Multiple Level Intertransverse Process Block

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Single Level Intertransverse Process BlockActive comparator 1 intervention
Group B: Multiple Level Intertransverse Process BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
0, 1, 4, 8, 12, and 24 hours after surgery

Secondary outcomes

1

Total opioid consumption via patient-controlled analgesia (PCA)

Time frame
Within the first 24 hours postoperatively
2

Requirement for rescue analgesia

Time frame
Within the first 24 hours postoperatively
3

Block performance time

Time frame
During the block procedure
4

Block-related and systemic side effects

Time frame
Within the first 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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