Trials / Recruiting
RecruitingNCT05445960
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 390 (estimated)
- Sponsor
- Oregon Health and Science University · Academic / Other
- Sex
- All
- Age
- 18 Years – 89 Years
- Healthy volunteers
- Not accepted
Summary
This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.
Detailed description
Tourniquets are widely accepted as "safe" for up to two hours of continued use, despite known risks and a paucity of literature supporting this duration. Complications of tourniquets include tourniquet site pain, increased surgical site pain and swelling from reperfusion, neuropraxia, vascular injury, functional weakness, and decreased muscle endurance. Similar to compartment syndrome, tourniquets eliminate the tissue perfusion gradient necessary for oxygen, glucose, and lactic acid exchange. Lack of molecular exchange within the tissue is thought to result in tissue anoxia and acidosis, leading to cellular death of skeletal muscle and nerves. This study randomizes patients undergoing ankle fracture surgery to tourniquet or no-tourniquet arms and studies outcomes including continuous intramuscular pH during and after surgery, and patient-reported outcomes and functional measures up to 3 months postoperatively.
Conditions
- Ankle Fractures
- Ankle Fracture - Lateral Malleolus
- Ankle Fracture, Bimalleolar
- Ankle Fracture, Trimalleolar
- Ankle Fracture - Medial Malleolus
- Maisonneuve's Fracture
- Syndesmotic Injuries
- Fibula Fracture
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Tourniquet | This arm will have a tourniquet placed about the thigh and inflated to 250mmHg for the duration of ankle fracture surgery or 2 hours, whichever is shorter. |
Timeline
- Start date
- 2021-08-17
- Primary completion
- 2026-03-17
- Completion
- 2027-03-17
- First posted
- 2022-07-06
- Last updated
- 2025-03-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05445960. Inclusion in this directory is not an endorsement.