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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT02898103
Eligibility Criteria:
Inclusion Criteria:
* Undergoing orthopedic surgical procedure that frequently results in moderate-to-severe postoperative pain
* At least 18 years of age
* Able to understand and willing to take part in study and adhere to all study requirements
Exclusion Criteria:
* Postoperative analgesic plan includes a single-injection peripheral nerve block in the surgical extremity
* Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
* Known neuro-muscular deficit of the target nerve(s)
* Anticipated MRI within the following 2 weeks
* Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk in the opinion of the investigator
* Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
* History of bleeding disorder
* Antiplatelet or anticoagulation therapies other than aspirin
* Allergy to all local anesthetic agents such as lidocaine or previous reaction to anesthesia
* Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
* Any other condition that may interfere with ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement) as determined by the Investigators
* Incarceration
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02898103
Study Brief:
Protocol Section:
NCT02898103