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Serratus Anterior Plane Block, Ultrasound vs Anatomical Landmark Guided.

NCT ID: NCT06340880

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-10

Study Completion Date

2024-10-20

Brief Summary

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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

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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

Conditions

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Serratus Anterior Plane Block

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Serratus anterior plane block

Intervention Type OTHER

ultrasound guided SAPB vs anatomical landmark guided SAPB

Interventions

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Serratus anterior plane block

ultrasound guided SAPB vs anatomical landmark guided SAPB

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Wesameldin Abelrahman Soltan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wesamelsin A Soltan, MD

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

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Menoufia University Hospitals

Shibīn al Kawm, Menoufia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SAPB

Identifier Type: -

Identifier Source: org_study_id