RISS Versus SPSIP Block in Modified Radical Mastectomy

NCT07659990 | Recruiting

• 2 other identifiers: MRM-2025-KAEK472025-KAEK-47
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized double-blind controlled trial aims to compare the postoperative analgesic efficacy and dermatomal spread of rhomboid intercostal-subserratus plane (RISS) block and serratus posterior superior intercostal plane (SPSIP) block in patients undergoing modified radical mastectomy. Postoperative pain scores, opioid consumption, rescue analgesic requirements, block-related complications, and quality of recovery outcomes will be evaluated.

Conditions

Postoperative Pain; Breast Cancer

Keywords

Breast Neoplasms; Postoperative Pain; Anesthesia, Conduction

Outcome Measures

Primary Outcomes (1)

• Total Postoperative Opioid Consumption

  Total opioid consumption during the first 24 hours after modified radical mastectomy.

  24 hours after surgery

Secondary Outcomes (6)

• Postoperative Pain Scores

  0-24 hours after surgery

• Compartmental Pain Scores Using Numeric Rating Scale

  0-24 hours after surgery

• Dermatomal Sensory Block Distribution

  30 minutes after block performance

• Quality of Recovery-15 Score

  24 hours after surgery

• Intraoperative Remifentanil Consumption

  During surgery

Study Arms (2)

RISS Block

EXPERIMENTAL

Patients will receive an ultrasound-guided rhomboid intercostal-subserratus plane (RISS) block before modified radical mastectomy for postoperative analgesia.

Procedure: Rhomboid Intercostal-Subserratus Plane Block

SPSIP Block

EXPERIMENTAL

Patients will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block before modified radical mastectomy for postoperative analgesia.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Interventions

Rhomboid Intercostal-Subserratus Plane Block PROCEDURE

Ultrasound-guided rhomboid intercostal-subserratus plane block performed before modified radical mastectomy for postoperative analgesia.

RISS Block

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

Ultrasound-guided serratus posterior superior intercostal plane block performed before modified radical mastectomy for postoperative analgesia.

SPSIP Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18-75 years
• ASA physical status I-III
• Scheduled for elective unilateral modified radical mastectomy with axillary dissection under general anesthesia
• Provision of written informed consent

You may not qualify if:

• Anticoagulant therapy
• Bleeding diathesis
• Known allergy to local anesthetics or opioids
• Infection at the block application site or previous surgery in the block area
• Cognitive impairment preventing NRS assessment
• Pregnancy or lactation
• Chronic opioid use
• Severe hepatic or renal failure
• Refusal to participate in the study
• Technical inability to perform the block or failed block

Sponsors & Collaborators

• Ferit Yetik: lead
• Bursa City Hospital: collaborator

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mürsel Ekinci, MD

  Bursa City Hospital

  PRINCIPAL INVESTIGATOR

• Yusuf Alan, MD

  Bursa City Hospital

  STUDY CHAIR

Central Study Contacts

Yusuf Alan, MD

CONTACT

+905396210977; dryusufalan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group allocation. Regional blocks will be performed by an anesthesiologist not involved in postoperative assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Participants will be randomized in a 1:1 ratio to receive either a Rhomboid Intercostal-Subserratus Plane (RISS) block or a Serratus Posterior Superior Intercostal Plane (SPSIP) block before modified radical mastectomy. Outcomes will be compared between two parallel groups.

Study Record Dates

• First Submitted: June 12, 2026
• First Posted: June 22, 2026
• Study Start: June 19, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

TU (1)