Clinical trial NCT06340880: Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.
Official title: Serratus Anterior Plane Block: Ultrasound Guided Versus Anatomical Landmark, A Randomized Control, Non-Inferiority Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Serratus Anterior Plane Block
Keywords: serratus anterior block
gynecomastia
anatomical landmark
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male patients with gynecomastia

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

Eligibility criteria: 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.

Primary outcomes:
measure: visual analouge score (VAS)
timeFrame: the first hour, postoperative
Secondary outcomes:
measure: first call of analgesia
timeFrame: in the first 24 hours
measure: incidence of complications
timeFrame: in the first 24 hours
measure: patient satisfaction
timeFrame: in the first 24 hours
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University Hospitals
state: Menoufia
Study officials:
affiliation: Menoufia University
name: Wesamelsin A Soltan, MD
role: PRINCIPAL_INVESTIGATOR
References: