Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block for Postoperative Analgesia Following Breast Cancer Surgery With Axillary Lymph Node Dissection: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- postoperative pain intensity (VAS score)
Study Overview
Brief Summary
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.
Detailed 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Patients who meet the exclusion criteria will be withdrawn from the study.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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SERRATUS POSTERİOR SUPERİOR İNTERCOSTAL PLANE BLOCK (SPSIPB)
PATİENTS İN THİS GROUP WİLL RECEİVE AN ULTRASOUND-GUİDED SERRATUS POSTERİOR SUPERİOR İNTERCOSTAL PLANE BLOCK(SPSIPB) FOR POSTOPERATİVE ANALGESİA FOLLOWİNG BREAST CANCER SURGERY
Intervention: Serratus posterior superior intercostal plane block (Procedure)
RHOMBOİD İNTERCOSTAL BLOCK(RIB)
PATİENTS İN THİS GROUP WİLL RECEİVE AN ULTRASOUND-GUİDED RHOMBOİD İNTERCOSTAL BLOCK(RIB) FOR POSTOPERATİVE ANALGESİA FOLLOWİNG BREAST CANCER SURGERY
Intervention: Rhomboid intercostal plane block (Procedure)
Outcomes
Primary Outcomes
postoperative pain intensity (VAS score)
Time Frame: 0, 1, 4, 8, 12, and 24 hours after surgery
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(Within the first 24 hours postoperatively)
- Requirement for rescue analgesia(Within the first 24 hours postoperatively)
- Block performance time(During the block procedure (intraoperative period))
- Block-related and systemic side effects(Within the first 24 hours postoperatively)
- İncedence of postoperative nausea and vomiting(Within the first 24 hours postoperatively)
- Patient and Surgeon satisfaction assessed using a Likert scale(At 24 hours postoperatively)
- Quality of recovery assessed using the QoR-15 questionnaire(At 24 hours postoperatively)
Investigators
Mustafa Kılın
Consultant Anesthesiologist
Antalya City Hospital