CompletedNot Applicable

A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery

United States79 participantsStarted 2022-03-21

Plain-language 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 pain and apply them to the surgical population. One potential non-opioid method of pain relief is the use of the nCAP Nano Patch, placed topically on the site of pain. The objective of this study is to investigate the efficacy of the nCAP Signal Relief Patch in reducing the perioperative opioid requirement in patients undergoing primary unilateral total hip or knee replacement surgery.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * \>18 years of age * Scheduled for elective primary unilateral hip or knee replacement Exclusion Criteria: * 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

What they're measuring

Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement

Timeframe: Day of surgery up to 30 days post-operative

Trial details

NCT IDNCT05252858

SponsorJacques E. Chelly

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-08

Results submitted2023-10-08

View on ClinicalTrials.gov More Opioid Use trials