Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery

NCT07763756 | Not Yet Recruiting

• 1 other identifier: SİNGLEvsMULTİPLE/ITP
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

ITP; Intertransverse Process Block

Outcome Measures

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.

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

Secondary Outcomes (7)

• Total opioid consumption via patient-controlled analgesia (PCA)

  Within the first 24 hours postoperatively

• Requirement for rescue analgesia

  Within the first 24 hours postoperatively

• Block performance time

  During the block procedure

• Block-related and systemic side effects

  Within the first 24 hours postoperatively

• Patient and Surgeon satisfaction assessed using a Likert scale

  At 24 hours postoperatively

Study Arms (2)

Single Level Intertransverse Process Block

ACTIVE COMPARATOR

Procedure: Single Level Intertransverse Process Block

Multiple Level Intertransverse Process Block

ACTIVE COMPARATOR

Procedure: Multiple Level Intertransverse Process Block

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.

Multiple Level Intertransverse Process Block

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.

Single Level Intertransverse Process Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Ability to understand and use the patient-controlled analgesia (PCA) device
• Ability to provide written informed consent

You may not qualify if:

• Refusal to participate
• Allergy to local anesthetics
• Infection at the injection site
• Coagulopathy or ongoing anticoagulant therapy
• Chronic opioid use or opioid dependence
• Severe hepatic or renal insufficiency
• Pregnancy or breastfeeding
• Cognitive impairment or inability to communicate pain scores
• Body mass index (BMI) \<18 or \>35 kg/m²

Sponsors & Collaborators

• Antalya City Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

MUSTAFA KILIN, CONSULTANT ANESTHESİOLOGİST

CONTACT

+905464569218; mustafa.kilin90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant anesthesiology

Study Record Dates

• First Submitted: August 9, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share