Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

NCT06340880 | Completed

• 1 other identifier: SAPB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Serratus Anterior Plane Block

Keywords

serratus anterior block; gynecomastia; anatomical landmark

Outcome Measures

Primary Outcomes (1)

• visual analouge score (VAS)

  11 point scale, 0 means no pain, 10 means worst pain.

  the first hour, postoperative

Secondary Outcomes (3)

• first call of analgesia

  in the first 24 hours

• incidence of complications

  in the first 24 hours

• patient satisfaction

  in the first 24 hours

Study Arms (1)

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

Interventions

Serratus anterior plane block OTHER

ultrasound guided SAPB vs anatomical landmark guided SAPB

ultrasound vs anatomical landmark SAPB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

male patients with gynecomastia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Location

MeSH Terms

Conditions

Gynecomastia

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Wesamelsin A Soltan, MD

  Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 2, 2024
• Study Start: April 10, 2024
• Primary Completion: October 15, 2024
• Study Completion: October 20, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2-3 months and will be available forever

Locations

EG (1)