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/15805957/Actively Recruiting
Led by Oregon Health and Science University · Updated on 2025-03-24
390
Participants Needed
1
Research Sites
52 weeks
Total Duration
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
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
L
Lara Atwater, MD
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Oregon Health and Science University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Tourniquet Used During Surgery | No Tourniquet Used During Surgery |
|---|---|---|
| What it is | Surgical fixation of ankle fractures with a thigh tourniquet applied and inflated to 250mmHg for the operation or for up to 2 hours. | Surgical fixation of ankle fractures performed without any intraoperative tourniquet. |
| Role in the trial | Evaluated to determine the effect of intraoperative tourniquet on limb pH, physical function, pain interference, and other recovery outcomes. | Assessed as a comparison group to determine outcomes when ankle fracture surgery is performed without a tourniquet. |
| Primary use | Helps provide a bloodless field for improved visualization during ankle fracture surgery. | Allows surgical fixation without tourniquet-related effects while maintaining hemostasis by other means. |
| How it is given or performed | A tourniquet cuff is placed on the thigh and inflated to 250mmHg before the surgical incision, then released within 2 hours or at end of procedure. | Surgical fixation is performed with standard techniques for hemostasis but no tourniquet is applied or inflated. |
| Evidence status | Tourniquet use in ankle fracture surgery is widely practiced, but published studies suggest it may increase post-operative swelling and pain compared to no tourniquet. | Avoiding tourniquet may lead to less swelling and lower post-operative pain intensity after ankle fracture surgery, though results may vary. |
| Important limitations | Use of a thigh tourniquet can increase intraoperative and post-operative pain and swelling, and may not benefit all patients compared to other hemostasis methods. | No tourniquet approach may occasionally result in increased bleeding during surgery, which can affect visualization for the surgeon. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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