Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery

NCT07536867 | Not Yet Recruiting

• 1 other identifier: SPSIP-RIB-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective interventional study aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) block and Rhomboid Intercostal Block in patients undergoing breast cancer surgery with axillary lymph node dissection. The type of regional anesthesia technique will be determined by the attending anesthesiologist based on clinical judgment, without randomization. The primary outcome is postoperative pain intensity assessed by the 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 complications (hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a Likert scale, and quality of recovery assessed using the QoR-15 questionnaire.

Conditions

Breast Cancer; Lymph Node Dissection; Postoperative Pain; Mastectomy

Keywords

SPSIP; rhomboid intercostal block; regional anesthesia; axillary dissection; serratus posterior superior intercostal plane 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 (intraoperative period)

• 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)

SERRATUS POSTERİOR SUPERİOR İNTERCOSTAL PLANE BLOCK (SPSIPB)

ACTIVE COMPARATOR

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

RHOMBOİD İNTERCOSTAL BLOCK(RIB)

ACTIVE COMPARATOR

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

Interventions

Rhomboid intercostal plane block PROCEDURE

Ultrasound-guided rhomboid intercostal block (RIB) performed for postoperative analgesia following breast cancer surgery.

RHOMBOİD İNTERCOSTAL BLOCK(RIB)

Serratus posterior superior intercostal plane block PROCEDURE

Ultrasound-guided serratus posterior superior intercostal plane block (SPSIPB) performed at the upper thoracic level for postoperative analgesia following breast cancer surgery.

SERRATUS POSTERİOR SUPERİOR İNTERCOSTAL PLANE BLOCK (SPSIPB)

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 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

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

Study Sites (1)

Antalya City Hospital

Antalya, Turkey (Türkiye)

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anesthesiologist

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)