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Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06340880
Enrollment
40
Registered
2024-04-02
Start date
2024-04-10
Completion date
2024-10-20
Last updated
2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serratus Anterior Plane Block

Keywords

serratus anterior block, gynecomastia, anatomical landmark

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

Interventions

OTHERSerratus anterior plane block

ultrasound guided SAPB vs anatomical landmark guided SAPB

Sponsors

Menoufia University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
visual analouge score (VAS)the first hour, postoperative11 point scale, 0 means no pain, 10 means worst pain.

Secondary

MeasureTime frameDescription
incidence of complicationsin the first 24 hourspneumothorax, skin bruises
patient satisfactionin the first 24 hours1-5 score, 1 means very dissatisfied, 5 means very satisfied
first call of analgesiain the first 24 hoursthe time for the first call of analgesia

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026