Comparison of WALANT and spinal anesthesia for ankle fractures
WALANT in Ankle Fractures (Wide-Awake Local) Anesthesia No Tourniquet) and Applied Under Spinal Anesthesia Comparison of Clinical Results of Surgical Treatment; Randomized Prospective Clinical Research
This study is testing whether a new method called WALANT is better than spinal anesthesia for patients having surgery on ankle fractures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Istanbul University Academic / other |
| Locations | 1 site (Istanbul, Çapa / Fatih) |
| Trial ID | NCT06077344 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the clinical outcomes of ankle fracture patients undergoing surgery with either the WALANT technique or spinal anesthesia. A total of 50 patients will be prospectively followed for one year, with 25 patients in each group. Key parameters such as patient demographics, fracture characteristics, and surgical details will be assessed to determine the effectiveness of the WALANT approach compared to traditional spinal anesthesia. The study is being conducted at Istanbul University, focusing on isolated bimalleolar and trimalleolar ankle fractures.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with isolated bimalleolar or trimalleolar ankle fractures.
Not a fit: Patients with open fractures above grade 1, certain vascular or neurological conditions, or those requiring fixation for posterior malleolus fractures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the benefits of WALANT anesthesia, potentially improving patient comfort and surgical outcomes.
How similar studies have performed: While WALANT has been used in various surgical contexts, this specific application for ankle fractures is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: -\>18 years * Isolated bimalleolar ankle fracture * Isolated trimalleolar ankle fracture (posterior malleolar fracture will not be operative) Exclusion Criteria: * \< 18 years * vasculitis * Raynaud's disease * Peripheral vascular disease * peripheral neuropathy * Lidocaine and epinephrine hypersensitivity * Grade \>1 open fractures * Maisonneuve, talus and posterior malleolus (requires fixation) fractures * multitrauma
Where this trial is running
Istanbul, Çapa / Fatih
- Istanbul University, Istanbul Faculty of Medicine, Department Orthopaedics and Traumatology — Istanbul, Çapa / Fatih, Turkey (Recruiting)
Study contacts
- Study coordinator: Oğuzhan Albayrak
- Email: oguzhanorto@gmail.com
- Phone: 02124142000 - 31740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.