Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

Completed

• Conditions: Serratus Anterior Plane Block
• Interventions: Other: Serratus anterior plane block

• Registration Number: NCT06340880
• Lead Sponsor: Menoufia University

Brief 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.

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 Timeline

• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-29
• Study First Posted: 2024-04-02
• Study Start: 2024-04-10
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-29
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ultrasound vs anatomical landmark SAPB	Serratus anterior plane block	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.

Primary Outcome Measures

Name	Time	Method
visual analouge score (VAS)	the first hour, postoperative	11 point scale, 0 means no pain, 10 means worst pain.

Secondary Outcome Measures

Name	Time	Method
first call of analgesia	in the first 24 hours	the time for the first call of analgesia
incidence of complications	in the first 24 hours	pneumothorax, skin bruises
patient satisfaction	in the first 24 hours	1-5 score, 1 means very dissatisfied, 5 means very satisfied

Trial Locations

Locations (1)

Menoufia University Hospitals; 🇪🇬 Shibīn Al Kawm, Menoufia, Egypt