Language: BG BG
← Back to results
Not yet recruiting Not applicable NCT07536867

Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block for Postoperative Analgesia Following Breast Cancer Surgery With Axillary Lymph Node Dissection

No applicable phase (e.g. observational)
Conditions: Breast Cancer Lymph Node Dissection Postoperative Pain Mastectomy

Sponsor: Antalya City Hospital

trial.available_in: БГ
Overview
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) and Rhomboid Intercostal Block in patients undergoing Breast Cancer Surgery With Axillary Lymph Node Dissection. 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.
Description
Study Objective This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) and Rhomboid Intercostal Block on Visual Analog Scale (VAS) scores in patients undergoing breast cancer surgery with axillary lymph node dissection. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours and postoperative recovery quality. Materials and Methods: This prospective, randomized clinical study will include voluntary female patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) \<35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain. Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration. Study Groups and Block Procedures: Group SPSIP will receive a unilateral SPSIP block, and Group RIB will receive a unilateral RIB block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered. SPSIP Block: The Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of the scapula at the level of the second and third ribs on the surgical side. Anatomical landmarks, including the trapezius, rhomboid major muscle (RMM), serratus posterior superior muscle (SPSM), and the second and third ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be inserted into the fascial plane between the SPSM and the third rip. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered. The block p
Who can participate
Inclusion Criteria: * Female patients aged 18-65 years * ASA physical status I-III * Scheduled for elective breast cancer surgery with axillary lymph node dissection * 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 Exclusion Criteria: * 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
Interventions
Serratus posterior superior intercostal plane block
PROCEDURE
Rhomboid intercostal plane block
PROCEDURE
Locations

Location information is not available.

Technical details
Status
Not yet recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Female only
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
30.03.2026
Completion date
30.04.2027
Registry ID
NCT07536867
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.