Serratus Anterior Plane Block: Ultrasound Guided Versus Anatomical Landmark, A Randomized Control, Non-Inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Serratus Anterior Plane Block
- Sponsor
- Menoufia University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- visual analouge score (VAS)
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Wesameldin Abelrahman Soltan
Associate Professor
Menoufia University
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.
Outcomes
Primary Outcomes
visual analouge score (VAS)
Time Frame: the first hour, postoperative
11 point scale, 0 means no pain, 10 means worst pain.
Secondary Outcomes
- first call of analgesia(in the first 24 hours)
- incidence of complications(in the first 24 hours)
- patient satisfaction(in the first 24 hours)