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NCT05445960NARecruiting

Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery

Oregon Health and Science University

Start Date

8/17/2021

Completion Date

3/17/2027

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.

Eligibility Criteria

Age Range: 18 years to 89 years

Inclusion Criteria: * Adult patients (18 years to 89 years) undergoing surgical ankle fracture fixation at OHSU Exclusion Criteria: * sepsis * other significant long bone or internal injuries (including ipsilateral limb injuries).

Interventions

PROCEDURE

Tourniquet

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Conditions

Ankle FracturesAnkle Fracture - Lateral MalleolusAnkle Fracture, BimalleolarAnkle Fracture, TrimalleolarAnkle Fracture - Medial MalleolusMaisonneuve's FractureSyndesmotic InjuriesFibula Fracture

Locations

Oregon Health and Science University

Portland, Oregon 97239

United States