NCT06100419

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
Last Updated

October 26, 2023

Status Verified

October 1, 2023

Enrollment Period

1 month

First QC Date

October 14, 2023

Last Update Submit

October 24, 2023

Conditions

Keywords

serratus posterior superior intercostal plane blockregional anaesthesiapostmastectomy paininterfascial plane blocks

Outcome Measures

Primary Outcomes (1)

  • numeric rate scores (NRS)

    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 Outcomes (1)

  • total tramadol consumption

    first 24 hours

Study Arms (1)

Block

EXPERIMENTAL

This group consists of patients who underwent SPSIP block.

Procedure: serratus posterior superior intercostal plane block

Interventions

With this newly introduced procedure added to the literature, patients undergoing breast surgeries are expected to experience reduced pain.

Also known as: SPSIPB
Block

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince patients undergoing breast surgery were selected, the group consists of female patients.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients who will undergo breast surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sivas Cumhuriyet University

Sivas, 58050, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: case series
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist/Department of Anaesthesiology and Reanimation

Study Record Dates

First Submitted

October 14, 2023

First Posted

October 25, 2023

Study Start

June 22, 2023

Primary Completion

July 22, 2023

Study Completion

July 22, 2023

Last Updated

October 26, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations