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

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Fibula Fracture; Maisonneuve's Fracture; Ankle Fracture - Lateral Malleolus; Syndesmotic Injuries; Ankle Fracture - Medial Malleolus; Ankle Fracture, Trimalleolar; Ankle Fractures; Ankle Fracture, Bimalleolar

Treatments: Procedure: Tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT05445960

STUDY00022560

Details and patient eligibility

About

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.

Full 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.

Enrollment: 390 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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390 participants in 2 patient groups

Tourniquet

Active Comparator group

Description:

This arm will have a tourniquet placed around the thigh inflated to 250mmHg for the duration of surgery (until splint placed) or 2 hours, whichever is shorter, during ankle fracture surgery.

Treatment:

Procedure: Tourniquet

No Tourniquet

No Intervention group

Description:

This arm will have a tourniquet placed around the thigh but NOT inflated for the duration of ankle fracture surgery.