Status:
COMPLETED
A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery
Lead Sponsor:
Jacques E. Chelly
Collaborating Sponsors:
nCap Medical
Conditions:
Opioid Use
Pain, Post Operative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Opioid addiction in post-operative patients is recognized but not fully understood; therefore, in order to address this growing crisis, it is essential to explore alternative approaches to managing pa...
Detailed Description
After signing an informed consent, subjects will complete the PROMIS Emotional Distress - Anxiety - Short Form 8a before completing any other questionnaires. Subjects who have a raw score \<19 will be...
Eligibility Criteria
Inclusion
- \>18 years of age
- Scheduled for elective primary unilateral hip or knee replacement
Exclusion
- Active clinical depression, anxiety or catastrophizing
- Raw score \>19 on PROMIS Emotional Distress - Anxiety - Short Form 8a
- Active alcoholism (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs)
- Severe chronic pain condition that requires daily preoperative opioid dependence
- Total surgery revision, bilateral hip or nee replacement, other procedures under the same anesthetic
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2022
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT05252858
Start Date
March 21 2022
End Date
October 8 2022
Last Update
April 18 2024
Active Locations (1)
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1
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15232