Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery (SPSIP-RIB)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Postoperative Pain; Mastectomy; Lymph Node Dissection
• Intervention / Treatment: Procedure: Serratus posterior superior intercostal plane block; Procedure: Rhomboid intercostal plane block

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Patients who meet the exclusion criteria will be withdrawn from the study.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:

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 performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.

RIB :

The Rhomboid İntercostal Block (RIB) 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 fifth and sixth ribs on the surgical side.

Anatomical landmarks, including the rhomboid major muscle (RMM) and intercostal muscles, 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 rhomboid major and intercostal muscles. 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 performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.

General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).

Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO₂ maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.

Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 0.15 mg/kg of intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).

Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.

Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24 hours postoperatively. All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.

Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.

Patient and Surgeon Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.

Nausea and Vomiting

Nausea and vomiting will be scored using a 4-point scale:

0 = none

• mild
• moderate
• severe

Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, or infection) will be recorded.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MUSTAFA KILIN, CONSULTANT ANESTHESİOLOGİST; Phone Number: +905464569218; Email: mustafa.kilin90@gmail.com

Study Locations

• Turkey (Türkiye)
  • Antalya, Turkey (Türkiye)
    • Antalya City Hospital
    • Contact: MUSTAFA KILIN; Phone Number: (0242) 455 53 53; Email: mustafa.kilin90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: Serratus posterior superior intercostal plane block; Ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) performed at the upper thoracic level for postoperative analgesia following breast cancer surgery.
Active Comparator: RHOMBOİD İNTERCOSTAL BLOCK(RIB); PATİENTS İN THİS GROUP WİLL RECEİVE AN ULTRASOUND-GUİDED RHOMBOİD İNTERCOSTAL BLOCK(RIB) FOR POSTOPERATİVE ANALGESİA FOLLOWİNG BREAST CANCER SURGERY	Procedure: Rhomboid intercostal plane block; Ultrasound-guided rhomboid intercostal block (RIB) performed for postoperative analgesia following breast cancer surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patient and surgeon satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction. Assessment will be performed at 24 hours postoperatively.	At 24 hours postoperatively
Quality of recovery assessed using the QoR-15 questionnaire	Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery. Assessment will be performed at 24 hours postoperatively.	At 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Antalya City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: regional anesthesia; axillary dissection; rhomboid intercostal block; serratus posterior superior intercostal plane block; SPSIP
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Pain, Postoperative; Breast Neoplasms
• Other Study ID Numbers: SPSIP-RIB-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No