SPSIP Block in Breast Surgeries for Postoperative Analgesia (SPSIPB)

October 24, 2023 updated by: Fatih Balci, Cumhuriyet University

Is Serratus Posterior Superior Intercostal Plane Block Effective in Modified Radical Mastectomy Surgeries?

The aim of this clinical study is to demonstrate that pain following breast surgeries can be reduced through the application of serratus posterior superior intercostal plane block (SPSIPB). Seven patients scheduled for breast surgery were included in the study. The primary research question it seeks to address is as follows: • Can SPSIPB be applied to reduce pain following breast surgeries? Participants are expected to provide accurate responses to the researcher's questions for the assessment of postoperative pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative analgesia techniques for breast surgeries encompass options such as Paravertebral Block, Erector Spinae Plane Block, Serratus Anterior Plane Block, and Pectoral Nerve Blocks. Although the Paravertebral Block is considered the gold standard for postmastectomy pain relief, its limited usage is primarily attributed to complications. SPSIPB's potential in thoracic surgeries has been noted, offering a broad sensory block suitable for MRM and axillary lymph node dissection. In this study, the effectiveness of SPSIP block for post-mastectomy pain has been investigated.

Study Type

Interventional

Enrollment (Actual)

7

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
      • Sivas, Turkey, 58050
        • Sivas Cumhuriyet University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Female patients who will undergo breast surgery

Exclusion Criteria:

  • unstable patients
  • patients with bleeding disorders
  • Patients allergic to local anesthetic drugs
  • Patients who did not agree to participate in the study
  • Patients with infection at the application site

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Block
This group consists of patients who underwent SPSIP block.
Procedure: serratus posterior superior intercostal plane block
With this newly introduced procedure added to the literature, patients undergoing breast surgeries are expected to experience reduced pain.
Other Names:
  • SPSIPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
numeric rate scores (NRS)
Time Frame: first 24 hours
The pain levels of patients are indicated with a number between 1 and 10. its means: 0=no pain, 10=worst pain.
first 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total tramadol consumption
Time Frame: first 24 hours
The total analgesic quantity that patients will consume for pain reduction.
first 24 hours

Collaborators and Investigators

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

Sponsor

Cumhuriyet 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)

June 22, 2023

Primary Completion (Actual)

July 22, 2023

Study Completion (Actual)

July 22, 2023

Study Registration Dates

First Submitted

October 14, 2023

First Submitted That Met QC Criteria

October 19, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SPSIPB

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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