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 @ 10:20 PM
Ignite Modification Date:
2025-12-24 @ 10:20 PM
NCT ID:
NCT02198235
Eligibility Criteria:
Inclusion Criteria:
* Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery
* Patients aged 18-75
* Patients scheduled for discharge from HSS after foot or ankle surgery
* A single-injection popliteal fossa nerve block is judged appropriate
* Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate is not an exclusion criterion)
Exclusion Criteria:
* \< 18 and \> 75
* Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac crest bone graft)
* Bilateral surgery
* Chronic pain (defined as regular use of opioid analgesics for \> 3 months)
* Chronic use of steroids (defined as regular use of steroids for \> 3 months)
* Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25% bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)
* Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent diabetes mellitus, etc.)
* Patients who have been diagnosed with altered pain perception or have lack of sensation
* Inability of the patient to describe postoperative pain (e.g. psychiatric disorder, dementia)
* Non-English speaking patients (the questionnaire is in English, and translations would have to be separately validated)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02198235
Study Brief:
Protocol Section:
NCT02198235