SPSIPB vs. SAPB in Breast Surgery

April 23, 2025 updated by: Merve Sena BAYTAR, Zonguldak Bulent Ecevit University

Serratus Posterior Superior Intercostal Plane Block Versus Serratus Anterior Plane Block for Breast Surgery: A Randomized Controlled Trial

The effects of the newly defined serratus posterior superior intercostal plane block and serratus anterior plane block on postoperative analgesia and quality of recovery in women undergoing breast surgery will be investigated.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

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 Locations

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

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 who have received informed consent form Patients who will undergo Breast Cancer Surgery aged between 18-65

Exclusion Criteria:

  • <18 years and >65 years
  • ASA ≥ IV
  • History of allergy to local anesthetics
  • Clinical diagnosis of coagulation disorders
  • Infection near the entry site
  • Chronic analgesic use Patients who will undergo bilateral Breast Cancer Surgery
  • Body mass index >35
  • Clinical diagnosis of Dementia or confusion
  • Lack of cooperation

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
No Intervention: Group Control
Active Comparator: Group SPSIPB
Procedure: Serratus Posterior Superior Intercostal Plane Block
administer 30 mL %0.25 bupivacain between third costa and serratus posterior superior muscle
Active Comparator: Group SAPB
Procedure: Serratus Anterior Plane Block
administer 30 mL %0.25 bupivacain between 5th costa and serratus anterior muscle in midaxiller line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative opioid consumption
Time Frame: up to 24 hour after surgery
total opioid consumption during postoperative 24 hours
up to 24 hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain scores
Time Frame: postoperative 2nd 6th, 12th 24th hour
Pain scores evaluate with Numeric rating scale. 0= no pain, 10= unbearable pain
postoperative 2nd 6th, 12th 24th hour
quality of recovery
Time Frame: postoperative 24 hour
Recovery quality will be measured with Quality of recovery-15 questionnaire
postoperative 24 hour

Collaborators and Investigators

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

Sponsor

Zonguldak Bulent Ecevit University

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)

April 1, 2025

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/01-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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