The Effect of Nerve Blocks on Analgesia in Breast Cancer Surgery (breast surgery)

May 22, 2026 updated by: Dilek Yamac, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block in Modified Radical Mastectomy Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, randomized, controlled clinical study is designed to compare the postoperative analgesic efficacy of the ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block and Serratus Anterior Plane (SAP) block in patients undergoing modified radical mastectomy under general anesthesia. Postoperative pain after breast cancer surgery remains an important clinical problem and may negatively affect respiratory function, early mobilization, recovery quality, patient satisfaction, and postoperative opioid consumption. Effective perioperative analgesia is therefore an essential component of enhanced recovery protocols in breast surgery.

Regional anesthesia techniques have increasingly been incorporated into multimodal analgesia strategies to reduce opioid-related adverse effects and improve postoperative pain control. The SAP block is widely used in breast and thoracic surgery due to its ability to provide analgesia to the lateral thoracic wall through blockade of the lateral cutaneous branches of the intercostal nerves. However, recently described fascial plane blocks such as the SPSIP block may provide broader dermatomal spread and more effective thoracic analgesia. Despite growing interest in the SPSIP block, evidence regarding its analgesic efficacy in breast surgery remains limited.

The study will include adult female patients scheduled for elective modified radical mastectomy under general anesthesia. Following enrollment and randomization, patients will be allocated to receive either ultrasound-guided SPSIP block or SAP block preoperatively in addition to standardized general anesthesia and multimodal analgesia protocols. All regional blocks will be performed under sterile conditions using ultrasound guidance by experienced anesthesiologists. Standard intraoperative monitoring will be applied throughout the surgical procedure.

Perioperative anesthetic management will be standardized as much as possible to minimize confounding factors affecting postoperative pain outcomes. Intraoperative opioid administration, hemodynamic parameters, and anesthetic requirements will be recorded. Postoperative analgesia protocols, including rescue analgesic administration criteria, will also be standardized for all participants.

The primary aim of the study is to evaluate and compare postoperative analgesic effectiveness between SPSIP and SAP blocks. Analgesic efficacy will be assessed using postoperative pain scores at predefined time intervals and cumulative opioid consumption during the postoperative period. Additional perioperative parameters related to recovery and analgesic quality will also be evaluated to determine the clinical utility of these interfascial plane blocks in breast surgery.

This study is expected to contribute to the current literature regarding novel regional anesthesia techniques for breast surgery and may help define the role of SPSIP block as an alternative or superior analgesic approach compared with SAP block in modified radical mastectomy patients.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye), 34668
        • Health Sciences University 2. Sultan Abdülhamid Han Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Serratus Posterior Superior Intercostal Plane (SPSIP) block
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
Ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.
Active Comparator: Serratus Anterior Plane (SAP) block
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)
Ultrasound-guided Serratus Anterior Plane (SAP) block performed preoperatively for postoperative analgesia in modified radical mastectomy surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain intensity assessed by Visual Analog Scale (VAS)
Time Frame: At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "the worst imaginable pain." VAS scores at rest and during movement will be recorded and compared between patients receiving ultrasound-guided superior posterior serratus intercostal plane (SPSIP) block and serratus anterior plane (SAP) block following modified radical mastectomy surgery. Higher VAS scores indicate greater pain severity and poorer analgesic efficacy.
At postoperative 1, 2, 4, 8, 12, and 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative remifentanil consumption
Time Frame: During surgery
Total intraoperative remifentanil consumption will be recorded and compared between the SPSIP block group and SAP block group.
During surgery
Total postoperative tramadol consumption within 24 hours
Time Frame: First 24 hours after surgery
Total tramadol consumption during the first 24 postoperative hours will be recorded to evaluate postoperative opioid requirements in both groups.
First 24 hours after surgery
Postoperative nausea and vomiting (PONV) scores
Time Frame: First 24 hours after surgery
Postoperative nausea and vomiting will be assessed using a standardized Postoperative Nausea and Vomiting (PONV) severity scale ranging from 0 to 3, where 0 indicates no nausea or vomiting, 1 indicates mild nausea, 2 indicates severe nausea or a single episode of vomiting, and 3 indicates multiple episodes of vomiting. PONV scores will be recorded and compared between groups during the postoperative period. Higher scores indicate more severe postoperative nausea and vomiting and therefore worse clinical outcomes.
First 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

October 16, 2026

Study Registration Dates

First Submitted

May 15, 2026

First Submitted That Met QC Criteria

May 15, 2026

First Posted (Actual)

May 22, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBU-ANESTEZİ-DMY-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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