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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT03334903
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age
* Receiving surgery for total knee replacement (TKR)
* Opioid naïve
* Agrees to use tracking diary to monitor opioid consumption
Exclusion Criteria:
* Over 75 years of age on the date of surgery
* If female, pregnant
* Has received investigational articles \< 30 days prior to enrollment or is currently receiving investigational products or devices
* Chronic pain syndrome
* Taking chronic narcotics and/or taking more than 10 mg of codeine per day, any amount of Hydrocodone, over 200 mg of tramadol per day, or any other narcotics prescribed for moderate or severe pain
* Involved in pain clinics for chronic pain, or pain that is not related to the surgical site
* On long-term gabapentin regimen
* Taking Lyrica or Gralise
* Known history of depression or has been treated for depression with medication
* Has entertained suicidal thoughts and behaviors
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03334903
Study Brief:
Protocol Section:
NCT03334903