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:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT02950558
Eligibility Criteria:
Inclusion Criteria:
* Referred for surgery for open reduction and internal fixation for ankle fracture
Exclusion Criteria:
* Unable to give informed consent in English
* Unable to complete surveys in English
* Unable to understand instructions for using pump in English
* Unavailable for followup
* Polytrauma; undergoing other surgeries or having other orthopedic injuries related to the precipitating cause of the ankle fracture
* Infection
* Peripheral vascular disease
* Diabetes
* Currently undergoing chemotherapy
* Pregnancy
* Currently lactating
* Heart disease or heart rhythm disorder or taking anti-arrhythmic drugs
* Severe renal impairment (Class 3 or worse kidney disease)
* Liver disease (cirrhosis or liver failure)
* Prior allergic reaction to any type of local anesthetic
* Taking therapeutic doses of anti-coagulants or anti-platelet therapy (prophylactic doses started because of hospital admission are not an exclusion)
* Currently taking antidepressants or other psychiatric medications
* Single shot local nerve block prior to surgery was ineffective
* Selected for neuraxial anesthesia rather than general anesthesia for the open reduction surgery
* Already receiving chronic analgesic therapy for a separate chronic pain condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02950558
Study Brief:
Protocol Section:
NCT02950558