Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02679560
Eligibility Criteria:
Inclusion Criteria:
1. age ≥18 years ≤ 70 years
2. Patient's s/p trauma, with confirmed femur and/or hip fractures with a planned admission to the hospital
3. Patient is ambulatory without assistance (e.g. walker, cane, caretaker) prior to incident.
Exclusion Criteria:
1. \>10 hours since presentation to the emergency department
2. History of seizure disorder, recent seizure or a document intra-cranial hemorrhage.
3. Central or peripheral neurologic deficit on presentation
4. Concern or compartment syndrome
5. Associated additional long bone fractures
6. End stage liver failure
7. Renal failure requiring dialysis
8. Pregnancy or breast feeding
9. Prisoners
10. Coagulopathy with INR \>1.5
11. Use of direct thrombin inhibitors (bivalirudin, argatroban, desirudin, dabigatran etexilate), or direct factor Xa inhibitors (rivaroxaban, apixaban, edoxaban)
12. Suspected prolonged intubation within first 12 hours secondary to respiratory failure other than peri-procedurally
13. Adults unable to consent
14. Pediatric patients \<18 years old
15. Patients exhibiting signs of shock upon admission, HR \>120 or SBP \<100 mmHg.
16. History of allergic reaction to local anesthetics
17. Administration of any other local anesthetic in the 2 hours prior to the study enrollment.
18. Distal femur fractures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02679560
Study Brief:
Protocol Section:
NCT02679560