The relationship between the use of tourniquet and the intensity of postoperative pain in surgically treated malleolar fractures.
H Omeroğlu, U Günel, A Biçimoğlu...
https://pubmed.ncbi.nlm.nih.gov/9429882Actively Recruiting
Phase Not Applicable
Age: 18Years - 89Years
All Genders
ID05445960
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Led by Oregon Health and Science University · Updated on 2025-03-24
390
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ankle fracture surgery patients to understand how using a tourniquet during the operation affects muscle pH, functional recovery, and patient-reported outcomes. The study focuses on comparing patients who have a tourniquet applied during surgery with those who do not, exploring potential complications like pain, swelling, nerve and muscle injury, and tissue changes due to lack of blood flow. Participants are randomly assigned to one of two groups: one with a tourniquet inflated around the thigh during surgery (up to 2 hours or until splint placement) and one with a tourniquet placed but not inflated. The study continuously measures muscle pH during and after surgery and tracks patient outcomes and physical function for up to 3 months post-surgery. During the study, participants will undergo assessments including patient-reported physical function and pain measures before surgery and 12 weeks afterward. Additional evaluations like pain scoring, limb swelling, mobility, range of motion, muscle strength, balance tests, and continuous pH monitoring occur at various points up to 12 weeks postoperatively. The study aims to link intraoperative tourniquet use with recovery and functional outcomes.
CONDITIONS
Brief Title
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
Who Can Participate
Age: 18Years - 89Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 to 89 years
- Scheduled for surgical ankle fracture fixation at Oregon Health and Science University
You will not qualify if you...
- Presence of sepsis or severe infection
- Other significant long bone or internal injuries, including injuries on the same limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 2 hours during surgery
Participants undergo ankle fracture surgery with or without a tourniquet applied to the thigh during the procedure.
1 visit (in-person) for surgery
Post-operative Follow-up
Duration - 12 weeks
Participants are monitored for recovery including limb pH measurements for 2 hours after surgery and functional and patient-reported outcomes assessed up to 12 weeks postoperatively.
Visits at 2 hours, 3 weeks, 6 weeks, and 12 weeks postoperatively
Trial Site Locations
Total: 1 location
1
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
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Research Team
L
Lara Atwater, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Tourniquets may increase postoperative swelling and pain after internal fixation of ankle fractures.
Gerhard Konrad, Max Markmiller, Andreas Lenich...
https://pubmed.ncbi.nlm.nih.gov/15805957Survey of tourniquet use in orthopaedic foot and ankle surgery.
Alastair S E Younger, Timothy P Kalla, James A McEwen...
https://pubmed.ncbi.nlm.nih.gov/15766423PROMIS and FAAM Minimal Clinically Important Differences in Foot and Ankle Orthopedics.
Man Hung, Judith F Baumhauer, Frank W Licari...
https://pubmed.ncbi.nlm.nih.gov/30282469Observations on the effects of tourniquet ischemia.
E F Wilgis
https://pubmed.ncbi.nlm.nih.gov/5114697