Status:
RECRUITING
Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Limb Occlusion Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Currently a standard tourniquet pressure is used for orthopedic surgeries. High tourniquet pressure had been associated with adverse side effects such as ischemia, muscle weakness, and post operative ...
Detailed Description
The study will start for each subject in the clinic setting during a standard pre-operative office visit. Consent for the study will be obtained after explaining all aspects of the study. The subjects...
Eligibility Criteria
Inclusion
- The research team will test the central hypothesis that LOP tourniquets will decrease pain and opioid use and improve patients outcomes on healthy adults (above the age of 18) undergoing either open carpal tunnel release, open reduction internal fixation distal radius fracture, cubital tunnel release, trigger finger release, thumb CMC arthroplasty, anterior cruciate ligament reconstruction, or total knee replacements
Exclusion
- Prescription pain medications for chronic conditions (\> 6 weeks)
- Patients who cannot use a tourniquet:( ex. Certain patients with fistulas or PVD, certain patient with Peripheral Vascular Disease)
- Prior trauma or surgery to the observed limb.
- Hypotension or hypertension that prevents accurate distal photoplenthysmography probe reading.
Key Trial Info
Start Date :
April 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04390425
Start Date
April 6 2018
End Date
December 1 2026
Last Update
January 30 2025
Active Locations (1)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030