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 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT03461120
Eligibility Criteria:
Inclusion Criteria:
* scheduled for a unilateral lower limb amputation distal to the femoral head and including at least one metatarsal bone
* continuous peripheral nerve blocks are planned for perioperative analgesia
* willing to have their perineural infusion extended for a total of 7 days
* willing to undergo ambulatory perineural infusion following hospital discharge
Exclusion Criteria:
* Known hepatic or renal insufficiency
* allergy to any study medication
* pregnancy
* incarceration
* inability to communicate with the investigators
* comorbidity precluding either perineural catheter insertion or subsequent ambulatory perineural infusion (e.g., current infection at the catheter insertion site, immune-compromised status of any etiology)
* weight \< 45 kg
* inability to contact the investigators during the perineural infusion, and vice versa (e.g., lack of telephone access)
* investigator opinion that the potential subject is not a good candidate for this particular study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03461120
Study Brief:
Protocol Section:
NCT03461120