Lower Tourniquet Pressure Study

Not Applicable

Completed

• Conditions: Hand Injuries; Upper Extremity Injury

• Registration Number: NCT04994405
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-08-05
• Study First Posted: 2021-08-06
• Study Start: 2022-07-15
• Primary Completion: 2024-09-27
• Study Completion: 2024-09-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• Adult patient age 18 or older
• Undergoing hand or upper extremity procedure
• Tourniquet is used for procedure
• Willingness and ability to consent

Exclusion Criteria

• Individuals with procedures that are over 120 minutes in length

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of the bloodless surgical field provided by lower tourniquet pressures	Immediately After surgery in recovery room time	Surgeon-completed questionnaire rating the quality of the bloodless operative field using a 4-point Likert scale ranging from 1 (excellent) meaning no blood in the surgical field to 4 (poor) meaning blood in the surgical field obscures view throughout the procedure. This survey will be completed immediately post-operatively.

Secondary Outcome Measures

Name	Time	Method
Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain	Immediately After surgery in recovery room time	Patient-completed questionnaire rating their tourniquet site pain post-operatively using the Visual Analogue Scale (VAS) ranging from 0 meaning no pain to 10 meaning worst possible pain. This survey will be completed post-operatively in the recovery unit.

Trial Locations

Locations (3)

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