Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Mastectomy

May 16, 2026 updated by: Fatma Acil,MD, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Mastectomy and Axillary Dissection: Evaluation of the Effect of Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia: A Multicenter, Randomized, Placebo-Controlled Trial

This study aims to evaluate the effect of serratus posterior superior intercostal plane (SPSIP) block on postoperative pain, opioid consumption, and analgesic requirements in patients undergoing mastectomy and axillary lymph node dissection

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a prospective, randomized, placebo-controlled, multicenter clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing mastectomy with axillary lymph node dissection. Postoperative pain following breast surgery is often significant and may increase opioid consumption and related adverse effects, highlighting the need for effective regional anesthesia techniques.

The SPSIP block is a novel ultrasound-guided interfascial plane block with emerging evidence in thoracic and chest wall procedures; however, its role in breast surgery remains unclear, particularly in placebo-controlled settings. This study aims to determine whether the SPSIP block provides additional benefit as part of a standardized multimodal analgesia approach.

Participants will be randomly assigned to receive either SPSIP block with local anesthetic or a placebo intervention under identical conditions, with blinding applied to all relevant parties. All patients will receive the same perioperative anesthesia and analgesia protocol.

The results of this study are expected to clarify the clinical value of SPSIP block in breast surgery and contribute to the development of evidence-based postoperative pain management strategies.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
    • Outside of the US
      • Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
        • Recruiting
        • Fatma Acil
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients aged 18-65 years
  • ASA physical status I-III
  • Scheduled for elective unilateral mastectomy with axillary lymph node dissection under general anesthesia
  • Able to understand and use the Numeric Rating Scale (NRS) for pain assessment
  • Provided written informed consent

Exclusion Criteria:

  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
  • Coagulopathy, thrombocytopenia (<100,000/mm³), or ongoing anticoagulant/antiplatelet therapy that cannot be discontinued
  • Infection or skin lesion at the injection site
  • Planned bilateral surgery or additional major surgical procedures
  • Chronic pain conditions or regular use of opioids, gabapentinoids, or centrally acting analgesics
  • Neurological or psychiatric conditions interfering with pain assessment
  • History of previous major thoracic or chest wall surgery on the same side
  • Pregnancy or breastfeeding
  • Refusal to participate or inability to provide informed consent

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Group
Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.
Procedure: SPSIP Block With Saline
Participants will receive an ultrasound-guided SPSIP block using normal saline under identical conditions.
Experimental: Serratus Posterior Superior Intercostal Plane Block Group
Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
Procedure: SPSIP Block With Bupivacaine
Participants will receive an ultrasound-guided SPSIP block using bupivacaine.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
24-hour cumulative opioid consumption
Time Frame: 24 hours
Total opioid consumption within the first 24 hours after surgery, recorded in milligrams.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Static postoperative pain intensity at rest
Time Frame: 0, 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity at rest will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
0, 1, 2, 6, 12, and 24 hours after surgery
Dynamic postoperative pain intensity during movement
Time Frame: 0, 1, 2, 6, 12, and 24 hours after surgery
Postoperative pain intensity during movement will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
0, 1, 2, 6, 12, and 24 hours after surgery
Rescue analgesia requirement
Time Frame: Within 24 hours after surgery
Number of patients requiring rescue analgesia and total rescue analgesic consumption.
Within 24 hours after surgery
Time to first rescue analgesia
Time Frame: Within 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesia.
Within 24 hours after surgery
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: Within 24 hours after surgery
Occurrence of nausea and/or vomiting during the postoperative period.
Within 24 hours after surgery
Block-related and opioid-related adverse events
Time Frame: Within 24 hours after surgery
Incidence of adverse events including local anesthetic toxicity, hematoma, infection, and opioid-related side effects.
Within 24 hours after surgery
Quality of Recovery-15 (QoR-15) score
Time Frame: 24 hours after surgery
Quality of recovery assessed using the QoR-15 questionnaire. Quality of Recovery-15 (QoR-15) questionnaire was used to assess postoperative recovery. The total score ranges from a minimum of 0 to a maximum of 150. A higher score represents a better recovery outcome (0 = extremely poor recovery, 150 = excellent recovery)
24 hours after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma Acil, M.D., Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27/01/2026-38

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared.

IPD Sharing Time Frame

Time Frame: "Starting 6 months and ending 36 months following article publication

IPD Sharing Access Criteria

Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to : acilfatma@gmail.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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