Trial Outcomes & Findings for Auricular Percutaneous Electrical Nerve Field Stimulation for Postoperative Pain Control in Adults (NCT NCT02892513)
NCT ID: NCT02892513
Last Updated: 2019-05-07
Results Overview
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
53 participants
Primary outcome timeframe
5 days
Results posted on
2019-05-07
Participant Flow
Participant milestones
| Measure |
Active
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
|
Inactive
Participants will have inactive device worn for 5 days during and after elective surgery.
Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Active
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
|
Inactive
Participants will have inactive device worn for 5 days during and after elective surgery.
Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
1 participant withdrew before device was applied and data not collected for analysis
Baseline characteristics by cohort
| Measure |
Active
n=28 Participants
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
|
Inactive
n=25 Participants
Participants will have inactive device worn for 5 days during and after elective surgery.
Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.05 years
STANDARD_DEVIATION 11.266 • n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
61.49 years
STANDARD_DEVIATION 11.273 • n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
58.77 years
STANDARD_DEVIATION 11.248 • n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
|
Sex: Female, Male
Female
|
14 Participants
n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
9 Participants
n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
23 Participants
n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
|
Sex: Female, Male
Male
|
14 Participants
n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
15 Participants
n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
29 Participants
n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
24 participants
n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
52 participants
n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
|
Open vs Laparoscopic Technique
Open
|
2 Participants
n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
7 Participants
n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
9 Participants
n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
|
Open vs Laparoscopic Technique
Laparoscopic
|
26 Participants
n=28 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
17 Participants
n=24 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
43 Participants
n=52 Participants • 1 participant withdrew before device was applied and data not collected for analysis
|
PRIMARY outcome
Timeframe: 5 daysPopulation: 1 participant withdrew before device was applied and data not collected for analysis.
Total inpatient narcotic use measured in oral morphine equivalents per day (OME)
Outcome measures
| Measure |
Active
n=28 Participants
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
|
Inactive
n=24 Participants
Participants will have inactive device worn for 5 days during and after elective surgery.
Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given.
|
|---|---|---|
|
Total Narcotic Consumption During Hospital Stay
|
90.79 Oral Morphine Equivalents per day (OME)
Standard Deviation 54.93
|
90.30 Oral Morphine Equivalents per day (OME)
Standard Deviation 43.03
|
Adverse Events
Active
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Inactive
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=28 participants at risk
Participants will have active percutaneous auricular neurostimulation for 5 days during and after elective surgery.
Percutaneous auricular neurostimulation: The Bridge device (manufactured by Key Electronics \[Jeffersonville, IN, USA\] and distributed by Innovative Health Solutions \[Versailles, IN, USA\]) provides continual neurostimulation for five days with alternating current.
|
Inactive
n=24 participants at risk
Participants will have inactive device worn for 5 days during and after elective surgery.
Sham percutaneous auricular neurostimulation: Identical in appearance to active, device, but no stimulation will be given.
|
|---|---|---|
|
Nervous system disorders
Stroke
|
3.6%
1/28 • Number of events 1 • 30 days
|
0.00%
0/24 • 30 days
|
|
Gastrointestinal disorders
GI Bleeding
|
0.00%
0/28 • 30 days
|
4.2%
1/24 • Number of events 1 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Carrie Y. Peterson, MD, MS
Medical College of Wisconsin
Phone: 414-955-5783
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place