Tourniquet Use for Ankle Fracture Surgery

Overseen By Lara Atwater, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Sepsis, Long bone injuries, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how using a tourniquet (a tight band that stops blood flow) during ankle fracture surgery might affect muscle health and recovery. Researchers aim to determine if outcomes differ between surgeries with an inflated tourniquet and those without. Individuals undergoing surgery to fix a broken ankle, without other serious injuries, might be suitable candidates. The goal is to discover whether a tourniquet aids or hinders recovery after surgery. As an unphased trial, this study allows participants to contribute to important research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that tourniquet use is safe for ankle fracture surgery?

Research shows that using a tourniquet during ankle fracture surgery is generally safe, though it can have some side effects. Studies have found that a tourniquet may cause more ankle swelling after surgery. For instance, one study noted that patients with a tourniquet experienced more swelling, measuring 19 mm, compared to 10 mm in those without a tourniquet, up to six weeks post-surgery.

Additionally, using a tourniquet might slightly increase the length of hospital stays. On average, patients with a tourniquet stayed about 1.79 days in the hospital, compared to 1.65 days for those without one. Using a tourniquet for up to 3 hours at pressures up to 300 mmHg does not seem to cause major wound problems.

While tourniquets can lead to more swelling and longer hospital stays, they do not appear to cause serious long-term harm. Although there are some risks, many patients handle tourniquets without major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of a tourniquet for ankle fracture surgery because it offers a potentially safer and more efficient method to control bleeding during the procedure. While traditional methods may not utilize a tourniquet, this approach involves inflating the tourniquet around the thigh to a specific pressure, which could improve the surgical field visibility and reduce operative time. This technique might also lead to less blood loss and quicker recovery times for patients, making it a promising alternative to current surgical practices. By comparing outcomes with and without the tourniquet, researchers hope to determine the optimal strategy for managing ankle fractures surgically.

What evidence suggests that tourniquet use is effective for ankle fracture surgery?

This trial will compare the use of a tourniquet with no tourniquet during ankle fracture surgery. Research has shown that using a tourniquet in such surgeries does not clearly improve outcomes. A review of studies found that tourniquets might reduce pain and shorten hospital stays, but strong evidence for this is lacking specifically in ankle fractures. Some studies indicate that while tourniquets can help keep the area blood-free for the surgeon, they don't significantly affect surgery duration or complication rates. Additionally, using a tourniquet can create challenges, such as increased risk for the anesthesiologist. Overall, current research leaves the benefits of using tourniquets in ankle surgeries uncertain. ^{1 3 6 7 8}

Who Is on the Research Team?

Lara Atwater, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

Adults aged 18 to 89 who are having surgery for an ankle fracture at OHSU can join this trial. It's not for those with other major bone or internal injuries, including on the same limb, or people with sepsis.

Exclusion Criteria

I have had serious injuries to my bones or internal organs.

I have had sepsis before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo ankle fracture surgery with or without tourniquet use

1 day

1 visit (in-person)

Postoperative Monitoring

Continuous intramuscular pH monitoring and initial recovery

2 hours

Intraoperative and immediate postoperative monitoring

Follow-up

Participants are monitored for functional measures and patient-reported outcomes

12 weeks

Multiple visits (in-person) at 3, 6, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tourniquet

Trial Overview The study is looking at how using a tourniquet during ankle surgery affects muscle pH levels and if there's any link between its use and how well patients recover functionally and what they report about their outcomes after surgery.

How Is the Trial Designed?

Group I: Tourniquet Active Control 1 Intervention

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.

Group II: No Tourniquet Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

Tourniquet use during extremity surgery is generally safe, but requires careful assessment of patient history and understanding of risks to prevent complications.

Knowledge of the physiological effects of tourniquets, including their impact on skin, vascular health, and postoperative pain, is essential for improving surgical outcomes and ensuring safe perioperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding and Optimizing Tourniquet Use During Extremity Surgery. Jensen, J., Hicks, RW., Labovitz, J.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3878853/

Meta-analysis on the efficacy of tourniquet on ankle trauma ... Smith et al. reported a meta-analysis of the efficacy of the tourniquet on foot and ankle surgery, suggesting that pain was reduced and hospital stay was ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1268773123001789

Tourniquet use in ankle arthroscopy: A systematic review All studies showed no statistically significant difference in mean surgical time and complication rate between the tourniquet and non-tourniquet groups. ...

3. withpower.com withpower.com/trial/phase-fractures-bone-7-2021-4348d

Tourniquet Use for Ankle Fracture Surgery Therefore, the effectiveness of tourniquet use in improving surgical outcomes for ankle fractures is not clearly supported by the available data.

4. journals.lww.com journals.lww.com/ejanaesthesiology/fulltext/2014/06001/tourniquet_use_during_ankle_surgery_leads_to.681.aspx

Tourniquet use during ankle surgery leads to increased... Tourniquet gives the surgeon a bloodless field and decreases blood loss, but it also leads to a number of challenges for the anaesthesiologist in the ...

5. wjgnet.com wjgnet.com/2218-5836/full/v15/i2/163.htm

Effect of ankle versus thigh tourniquets on post-operative ... It included 42 patients and demonstrated significantly less foot pain in the ankle tourniquet group within two weeks after surgery and higher ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8233247/

The risks associated with tourniquet use in lower limb trauma ... Tourniquet use was associated with greater ankle swelling up to six weeks post-operatively (10 mm versus 19 mm, p < 0.01) compared to surgery ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1067251618303636

Effect on Hospital Length of Stay of Tourniquet Use During ... As a secondary outcome, duration of operation was analyzed by analysis of covariance. Mean LOS was 1.79 ± 1.50 days in the tourniquet group and 1.65 ± 1.11 days ...

8. clinmedres.org clinmedres.org/content/20/3/141

Extended Tourniquet Times and the Impact on Wound ... This study suggests that tourniquet times from 2 to 3 hours in foot and ankle surgery with pressures up to 300 mmHg are not associated with a significant ...