nCAP Signal Relief Patch for Post-Operative Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Post-Operative Pain+1 MorenCAP Signal Relief Patch - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a topical patch can reduce the amount of opioids needed for pain relief after surgery.

Eligible Conditions
  • Opioid Use Disorder
  • Post-Operative Pain

Treatment Effectiveness

Study Objectives

1 Primary · 13 Secondary · Reporting Duration: Day 1, 2, 3, 7, 14, and 30 post-operative

Day 1
Change in post-operative pain rating using the Pain Catastrophizing Scale
Change in post-operative pain using a numerical rating scale
Number of participants who passed post-operative functionality test
Anxiety
Mental Depression
Post-operative change in sleep disturbance
Day 30
Efficacy of the nCAP Signal Relief Patch in affecting perioperative opioid requirement
Length of hospital stay
Day 30
Number of participants who experienced post-operative complications related to opioid use
Screening visit
Number of participants who passed pre-operative functionality test
Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to depression
Pre-operative pain rating using the Pain Catastrophizing Scale
Pre-operative sleep disturbance

Trial Safety

Trial Design

2 Treatment Groups

ERAS alone
1 of 2
nCAP + ERAS
1 of 2

Active Control

Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: nCAP Signal Relief Patch · No Placebo Group · N/A

nCAP + ERASExperimental Group · 2 Interventions: Standard of Care, nCAP Signal Relief Patch · Intervention Types: Other, Device
ERAS alone
Other
ActiveComparator Group · 1 Intervention: Standard of Care · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1, 2, 3, 7, 14, and 30 post-operative

Who is running the clinical trial?

nCap MedicalIndustry Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Jacques E. ChellyLead Sponsor
8 Previous Clinical Trials
629 Total Patients Enrolled
Jacques E Chelly, MDPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
210 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are over 18 years of age.