Comparison of the Postoperative Analgesic Efficacy of SAP and SPSIP Blocks in Patients Undergoing Mammoplasty (SPSIP)

January 11, 2026 updated by: Ilker Ital, Abant Izzet Baysal University
The aim is to compare the postoperative analgesic efficacy of serratus anterior plane block (SAPB) and serratus posterior superior intercostal plane block (SPSIPB) in patients undergoing mammoplasty surgery. To this end, a double-blind, randomized, controlled study has been designed. Female patients aged 18-65 years who will undergo mammoplasty surgery will be included in the study. Postoperative pain levels, opioid consumption, duration of analgesic requirement, and patient satisfaction will be evaluated in patients who receive fascial blocks for analgesic purposes.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Pain management after breast surgery plays an important role in the patients' recovery process. Therefore, investigating effective and safe analgesic methods is important for improving patient comfort in the postoperative period. The serratus anterior plane block (SAPB) is a regional anesthesia technique commonly used for pain control after breast surgery. SAPB has been shown to be effective in reducing postoperative pain and decreasing opioid consumption. In addition, SAPB is easy to perform and has a low risk of complications. The serratus posterior superior intercostal plane block (SPSIPB) is a new technique developed to provide analgesia in thoracic surgeries. SPSIPB has been reported to be effective in reducing postoperative pain and decreasing analgesic consumption. However, data on the efficacy of SPSIPB in breast surgery are limited. This study aims to compare the postoperative analgesic efficacy of SAPB and SPSIPB in patients undergoing mammoplasty. For this purpose, a double-blind, randomized, controlled trial has been designed.

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact Backup

Study Locations

  • Turkey (Türkiye)
      • Bolu, Turkey (Türkiye), 14030
        • Bolu Abant İzzet Baysal Medical School

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

Yes

Description

Inclusion Criteria:

  • Patients aged 18-85 years
  • Patients undergoing elective mammoplasty
  • ASA physical status I-II

Exclusion Criteria:

  • Patients who refuse to participate
  • Mentally disabled patients
  • Presence of infection at the injection site
  • Patients with coagulopathy
  • History of allergy or toxicity to local anesthetics
  • Patients with uncontrolled hypertension
  • Patients with uncontrolled diabetes mellitus
  • Patients with hepatic or renal failure
  • Pregnant, breastfeeding women

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SAPB Group
Serratus Anterior Plane Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
Procedure: Serratus Anterior Plane Block

Application of ultrasound-guided serratus anterior plane block for perioperative analgesia for mammoplasty operations. Serratus anterior plane block will be administered under general anesthesia before the surgery

Drug: Bupivacaine (Block Drug)

For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for each side.

Other Names:
  • SAP Block
Experimental: SPSIPB Group
Serratus Posterior Superior Intercostal Plane Block Group Drug: 0,25% Bupivacaine 0,5ml/kg (max.20ml) will be used for blocks for each side.
Procedure: Serratus Posterior Superior Intercostal Plane Block

Application of ultrasound-guided serratus anterior plane block for perioperative analgesia for mammoplasty operations. Serratus posterior superior intercostal plane block will be administered under general anesthesia before the surgery

Drug: Bupivacaine (Block Drug)

For block performances, 0,25% Bupivacaine will be used at 0,5 ml/kg (max. 20cc) for each side.

Other Names:
  • SPSIP Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid consumption
Time Frame: 0, 1, 6, 12 and 24 hours
Tramadol will be prepared at a concentration of 10 mg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 mg.
0, 1, 6, 12 and 24 hours
Postoperative pain scores (Numerical rating scale: NRS),Between 0 and 10 points (11 points in total), as the score increases, the pain intensity increases.
Time Frame: 0, 1, 6, 12 and 24 hours
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 1, 6, 12 and 24 hours.
0, 1, 6, 12 and 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first analgesic requirement
Time Frame: 24 Hour
Time from end of surgery to first analgesic requirement (min)
24 Hour
Patient satisfaction score
Time Frame: 24 Hour
Overall patient satisfaction scores will be assessed using a 5-point Likert scale,Minimum value: 1, Maximum value: 5, where higher scores indicate greater satisfaction.
24 Hour

Collaborators and Investigators

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

Sponsor

Abant Izzet Baysal University

Collaborators

Istanbul Medipol University Hospital
Karabuk Training and Research Hospital
Çam Sakura Şehir Hastanesi

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)

February 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Estimated)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-TF-AR-II-005 (Registry Identifier: SPSIP)

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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