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
-
-
Menoufia
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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.
|
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
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
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
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