Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

November 29, 2024 updated by: Wesameldin Abelrahman Soltan, Menoufia University

Serratus Anterior Plane Block: Ultrasound Guided Versus Anatomical Landmark, A Randomized Control, Non-Inferiority Trial

This prospective, double-blinded randomized controlled trial aims to compare the efficacy of the serratus anterior plane block (SAPB) ultrasound guided versus anatomical landmark guided for gynecomastia surgery. And to detect if the anatomical landmark technique is inferior or not to the ultrasound guided technique. We hypothesize that anatomical landmark guided SAPB is not inferior to ultrasound guided SAPB.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gynecomastia means enlarged male breast. Minimally invasive liposuction and surgical intervention are possible remedies for such cases. Postoperative pain can be controlled by opioids or regional blocks like serratus anterior plane block. Ultrasound guided blocks are associated with high success rate; however, anatomical landmark guided blocks may give similar results. Our hypothesis was that landmark guided serratus anterior plane block would be non-inferior to ultrasound plane block. Subjects presenting for gynecomastia surgery will receive ultrasound guided block in one side (US group) and landmark guided block in the other side (LM group) with the same volume (25) ml and concentration (0.25 %) of bupivacaine. The primary outcome will be visual analogue score. Secondary outcomes include patient satisfaction and incidence of complications like pneumothorax. It will be carried out over 40 male patients, aged from (18 - 60) year-old, with ASA I or II classes who will undergo elective gynecomastia surgery. Patient with BMI ≥ 35, history of previous chest surgery, drug abuse, allergy to local anesthetics, psychiatric problems or patient refusal will be excluded from participation

Study Type

Observational

Enrollment (Actual)

40

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

  • Egypt
    • Menoufia
      • Shibīn Al Kawm, Menoufia, Egypt
        • Menoufia University Hospitals

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

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

male patients with gynecomastia

Description

Inclusion Criteria:

  • male patients, aged from (18 - 60) year-old, with ASA I or II classes who will undergo elective gynecomastia surgery

Exclusion Criteria:

  • Patient with BMI ≥ 35, history of previous chest surgery, drug abuse, allergy to local anesthetics, psychiatric problems or patient refusal will be excluded from participation.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ultrasound vs anatomical landmark SAPB
Forty subjects presenting for gynecomastia surgery will receive ultrasound guided block in one side (US group) and landmark guided block in the other side (LM group) with the same volume (25) ml and concentration (0.25 %) of bupivacaine.
Other: Serratus anterior plane block
ultrasound guided SAPB vs anatomical landmark guided SAPB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analouge score (VAS)
Time Frame: the first hour, postoperative
11 point scale, 0 means no pain, 10 means worst pain.
the first hour, postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
first call of analgesia
Time Frame: in the first 24 hours
the time for the first call of analgesia
in the first 24 hours
patient satisfaction
Time Frame: in the first 24 hours
1-5 score, 1 means very dissatisfied, 5 means very satisfied
in the first 24 hours
incidence of complications
Time Frame: in the first 24 hours
pneumothorax, skin bruises
in the first 24 hours

Collaborators and Investigators

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

Sponsor

Menoufia University

Investigators

  • Principal Investigator: Wesamelsin A Soltan, MD, Menoufia 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 10, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

October 20, 2024

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 29, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAPB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol can be shared with other researchers after finishing the research.

IPD Sharing Time Frame

2-3 months and will be available forever

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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