NCT04824833

Brief Summary

The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients. We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

March 29, 2021

Last Update Submit

February 11, 2022

Conditions

Keywords

hemodynamicsserratus anterior plane blockopioid consumptionbreast surgery

Outcome Measures

Primary Outcomes (2)

  • hemodynamic stability

    effect of serratus anterior plane block on hemodynamic stability during breast surgery

    during surgery

  • opioid consumption

    effect of serratus anterior plane block on opioid consumption during breast surgery

    during surgery

Secondary Outcomes (1)

  • emergence time

    end of the surgery

Study Arms (2)

Serratus anterior plane block

ACTIVE COMPARATOR
Procedure: Serratus anterior plane block

control group

NO INTERVENTION

Interventions

local anesthetic application between serratus anterior muscle and 5th rib

Serratus anterior plane block

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 18-75,
  • ASA I-II-III risk group
  • Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
  • Patients whose informed consent was read and whose consent was obtained

You may not qualify if:

  • who do not want to participate in the study,
  • ASA IV-V patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University medicine faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Location

Related Publications (1)

  • Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.

MeSH Terms

Conditions

Bites and StingsBreast Neoplasms

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and InjuriesNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

March 1, 2021

Primary Completion

August 31, 2021

Study Completion

September 30, 2021

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations