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OpenTrials
Completed

NCT Number: NCT06340880

Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Observational

Primary location

Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Serratus anterior plane block

Other

ultrasound guided SAPB vs anatomical landmark guided SAPB

Primary outcomes

  1. visual analouge score (VAS)

    Time frame: the first hour, postoperative

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

Secondary outcomes

  1. first call of analgesia

    Time frame: in the first 24 hours

    the time for the first call of analgesia

  2. incidence of complications

    Time frame: in the first 24 hours

    pneumothorax, skin bruises

  3. patient satisfaction

    Time frame: in the first 24 hours

    1-5 score, 1 means very dissatisfied, 5 means very satisfied

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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