Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

Serratus Anterior Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340880
• Other study ID #: SAPB
• Status: Recruiting
• Start date: April 10, 2024
• Est. completion date: July 2024

Study information

• Verified date: May 2024
• Source: Menoufia University
• Contact: Wesamelsin A Soltan, MD
• Phone: +201010122125
• Email: wesamsultan[@]med.menofia.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Serratus Anterior Plane Block

Intervention

Other:
• Serratus anterior plane block
ultrasound guided SAPB vs anatomical landmark guided SAPB

Locations

Country	Name	City	State
Egypt	Menoufia University Hospitals	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual numerical rating score (NRS)	11 point scale, 0 means no pain, 10 means worst pain.	the first hour, postoperative
Secondary	first call of analgesia	the time for the first call of analgesia	in the first 24 hours
Secondary	incidence of complications	pneumothorax, hematoma formation	in the first 24 hours
Secondary	patient satisfaction	1-5 score, 1 means very dissatisfied, 5 means very satisfied	in the first 24 hours