A Prospective, Double-blinded, Randomized Controlled Trial Evaluating Effectiveness of Lower Tourniquet Pressures in Hand Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hand Injuries
- Sponsor
- NYU Langone Health
- Enrollment
- 93
- Locations
- 3
- Primary Endpoint
- Quality of the bloodless surgical field provided by lower tourniquet pressures
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Quality of the bloodless surgical field provided by lower tourniquet pressures
Time Frame: 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 Outcomes
- Effect of lower tourniquet pressures based on SBP on post-operative tourniquet site pain(Immediately After surgery in recovery room time)