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A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
This study design is a prospective, double-blinded, randomized controlled trial evaluating the quality of bloodless surgical field with lower tourniquet pressures based on systolic blood pressure (SBP) compared to standard tourniquet pressures. A secondary goal is to evaluate the effect of lower tourniquet pressures on post-operative tourniquet site pain. The rationale behind the study is to provide evidence-based guidelines on tourniquet use to continue providing quality surgical care while minimizing pain and potential harm to patients.
Patients undergoing hand and upper extremity surgery at our institution will be offered participation in this study. Consenting patients will be randomized in a double-blinded fashion to either standard tourniquet pressure of 250 mmHg or lower tourniquet pressures based on SBP. Demographic data will be recorded as well as details of the surgical procedure. Post-operatively, the operating surgeon will complete a questionnaire about the quality of bloodless surgical field and the patient will complete a questionnaire about post-operative pain. This study will enroll approximately 150 patients. Statistical analysis will be completed to analyze the effectiveness of the intervention.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
Yes
NYU Langone Brooklyn
Brooklyn, New York, United States
NYU Langone Orthopedic Hospital
New York, New York, United States
NYU Langone Orthopedic Center
New York, New York, United States
Start Date
July 15, 2022
Primary Completion Date
September 27, 2024
Completion Date
September 27, 2024
Last Updated
April 1, 2025
93
ACTUAL participants
Tourniquet Pressure
PROCEDURE
Lead Sponsor
NYU Langone Health
NCT04460521
NCT06016647
Data Source & Attribution
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