N/A
Completed N=69
A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery
Opioid Use Disorder · Pain, Post Operative
Source: ClinicalTrials.gov NCT05252858 ↗
Enrolled (actual)
69
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement — 82.1; 102.6 MME
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of the nCAP Signal Relief Patch in Affecting Perioperative Opioid Requirement |
82.1; 102.6 | — |
| SECONDARY Pre-operative Emotional Distress Related to Anxiety |
48.0; 44.1 | — |
| SECONDARY Post-operative Change in Emotional Distress Related to Anxiety |
9.85; 9.68 | — |
| SECONDARY Pre-operative Emotional Distress Related to Depression |
41.9; 40.4 | — |
| SECONDARY Post-operative Change in Emotional Distress Related to Depression |
42.25; 41.78 | — |
| SECONDARY Pre-operative Sleep Disturbance |
51.4; 47.4 | — |
| SECONDARY Post-operative Change in Sleep Disturbance |
49.86; 49.11 | — |
| SECONDARY Average Score of Functionality at Baseline |
3.7; 3.5 | — |
| SECONDARY Average Score of Functionality Post-Operative |
2.8; 2.7 | — |
| SECONDARY Pre-operative Pain Rating Using the Pain Catastrophizing Scale |
5.8; 6.8 | — |
| SECONDARY Change in Post-operative Pain Rating Using the Pain Catastrophizing Scale |
4.3; 4.6 | — |
| SECONDARY Length of Hospital Stay |
31.72; 40.85 | — |
| SECONDARY Change in Post-operative Pain Using a Numerical Rating Scale |
59.4; 101.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05252858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.