The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery

NCT07601490 | Not Yet Recruiting DMC

• 1 other identifier: SBU-ANESTEZİ-DMY-05
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain following modified radical mastectomy remains a significant clinical concern and may adversely affect patient recovery, opioid consumption, and overall patient satisfaction. Ultrasound-guided regional anesthesia techniques have gained increasing importance as part of multimodal analgesia strategies in breast surgery. The serratus anterior plane (SAP) block is a commonly used interfascial plane block for postoperative analgesia in thoracic and breast procedures. Recently, the serratus posterior superior intercostal plane (SPSIP) block has emerged as a novel regional anesthesia technique with potentially wider thoracic dermatomal spread and effective analgesic properties. This prospective randomized controlled study aims to compare the postoperative analgesic efficacy of the SPSIP block and SAP block in patients undergoing modified radical mastectomy under general anesthesia. Patients will be randomly allocated into two groups to receive either ultrasound-guided SPSIP block or SAP block preoperatively. Primary outcomes will include postoperative pain scores and opioid consumption within the first 24 hours after surgery. Secondary outcomes will include time to first analgesic request, rescue analgesic requirements, intraoperative hemodynamic parameters, postoperative nausea and vomiting, block-related complications, and patient satisfaction. The study is designed to evaluate whether SPSIP block provides superior postoperative analgesia compared with SAP block in modified radical mastectomy surgery.

Conditions

Breast Cancer Surgery Pain

Keywords

modified radical mastectomy; Serratus Posterior Superior Intercostal Plane Block; Serratus Anterior Plane Block; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain intensity assessed by Visual Analog Scale (VAS)

  Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS; 0-10) at rest and during movement in patients receiving ultrasound-guided SPSIP block or SAP block for modified radical mastectomy surgery. VAS scores will be compared between groups to assess the postoperative analgesic efficacy of the two regional anesthesia techniques.

  At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery

Secondary Outcomes (3)

• Intraoperative remifentanil consumption

  During surgery

• Total postoperative tramadol consumption within 24 hours

  First 24 hours after surgery

• Postoperative nausea and vomiting (PONV) scores

  First 24 hours after surgery

Study Arms (2)

Serratus Posterior Superior Intercostal Plane (SPSIP) block

EXPERIMENTAL

Participants assigned to this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.

Procedure: Serratus Posterior Superior Intercostal Plane Block

Serratus Anterior Plane (SAP) block

ACTIVE COMPARATOR

Participants assigned to this group will receive an ultrasound-guided Serratus Anterior Plane (SAP) block before induction of general anesthesia for modified radical mastectomy surgery. The block will be performed under sterile conditions by an experienced anesthesiologist using ultrasound guidance. Following the regional block procedure, standardized general anesthesia and postoperative multimodal analgesia protocols will be applied. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be recorded and evaluated.

Procedure: Serratus anterior plane block (SAP)

Interventions

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

Serratus Posterior Superior Intercostal Plane (SPSIP) block

Serratus anterior plane block (SAP) PROCEDURE

Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

Serratus Anterior Plane (SAP) block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Participants who self-identify as female and are scheduled for modified radical mastectomy surgery will be eligible for enrollment in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged between 18 and 65 years
• American Society of Anesthesiologists (ASA) physical status I-III
• Body Mass Index (BMI) \<35 kg/m²
• Normal International Normalized Ratio (INR) value and platelet count
• Normal liver and renal function tests
• Patients scheduled for elective modified radical mastectomy surgery

You may not qualify if:

• Bleeding diathesis
• Allergy to local anesthetic agents
• Suspected infection or inflammation at the planned block site
• ASA physical status IV or higher
• Long-term medication use due to chronic pain
• Advanced hepatic or renal failure
• Presence of severe pulmonary disease
• Use of any opioid medication within 24 hours before surgery
• Cognitive impairment
• Patients undergoing revision surgery

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

Related Publications (2)

• Arik E, Zengin M, Seker G, Kucuk O, Gungordu E, Ozguner Y, Alagoz A, Ergil J. Is the serratus posterior superior intercostal plane block a viable alternative to the erector spinae plane block for postoperative analgesia in breast surgery? A prospective, randomized trial. BMC Anesthesiol. 2025 Nov 29;26(1):11. doi: 10.1186/s12871-025-03531-y.

  PMID: 41318393 RESULT

• Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.

  PMID: 36107549 RESULT

Central Study Contacts

Dilek Metin Yamac, MD

CONTACT

+905054959792; ddilekmetin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants scheduled for elective modified radical mastectomy will be randomly assigned in a parallel-group design to receive either ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block or Serratus Anterior Plane (SAP) block prior to induction of general anesthesia. Randomization will be performed using a computer-generated allocation sequence. Both groups will receive standardized general anesthesia and postoperative multimodal analgesia protocols to minimize confounding variables. Postoperative pain scores, opioid consumption, rescue analgesic requirements, and perioperative adverse events will be compared between groups. Outcome assessments will be conducted at predefined postoperative time intervals by investigators blinded to group allocation whenever feasible. The study is designed to evaluate the comparative analgesic efficacy and safety profile of the two regional anesthesia techniques in breast surgery patients.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 16, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)