Using lower tourniquet pressure to reduce post-surgery pain
Limb Occlusion Pressure Tourniquets to Decrease Pain After Surgery
NA · The Methodist Hospital Research Institute · NCT04390425
This study is testing if using a lower tourniquet pressure during orthopedic surgery can help patients feel less pain and recover better afterwards.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Methodist Hospital Research Institute (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04390425 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of using Limb Occlusion Pressure (LOP) during orthopedic surgeries compared to standard tourniquet pressure. Patients will be randomly assigned to either the standard pressure group or the LOP group, where a device will calculate the appropriate pressure based on individual blood pressure. Participants will track their pain levels and opioid consumption for two weeks post-surgery, and complete outcome questionnaires at various intervals to assess their recovery. The goal is to determine if LOP can lead to less pain and better recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are healthy adults over 18 undergoing specific orthopedic procedures such as carpal tunnel release or ACL reconstruction.
Not a fit: Patients with chronic pain medication prescriptions, certain vascular conditions, or prior trauma to the limb may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce post-operative pain and opioid use for patients undergoing orthopedic surgeries.
How similar studies have performed: While the use of LOP is a novel approach, similar studies have indicated that optimizing tourniquet pressure can lead to improved outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: 1. Prescription pain medications for chronic conditions (\> 6 weeks) 2. Patients who cannot use a tourniquet:( ex. Certain patients with fistulas or PVD, certain patient with Peripheral Vascular Disease) 3. Prior trauma or surgery to the observed limb. 4. Hypotension or hypertension that prevents accurate distal photoplenthysmography probe reading.
Where this trial is running
Houston, Texas
- Houston Methodist Hospital — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Patrick McCulloch, MD — The Methodist Hospital Research Institute
- Study coordinator: Haley Goble, MHA
- Email: hmgoble@houstonmethodist.org
- Phone: 7134413930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Limb Occlusion Pressure