Trial Outcomes & Findings for NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries (NCT NCT03834142)
NCT ID: NCT03834142
Last Updated: 2022-08-03
Results Overview
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Results posted on
2022-08-03
Participant Flow
Participant milestones
| Measure |
Intervention-Kidney
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control-Kidney
Subject receives standard of care
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries
Baseline characteristics by cohort
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
42 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
42.4 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.Population: Kidney Transplant Donor
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption
|
8.3 mg morphine equivalent (MME)
Standard Deviation 9.6
|
33.5 mg morphine equivalent (MME)
Standard Deviation 37.3
|
SECONDARY outcome
Timeframe: Day of Surgery, 24 hours post-operative, 48 hours post-operativeInvestigate the efficacy of the NSS-2 BRIDGE device in changing perioperative NRS Pain scores in opioid-naïve patients undergoing either a total hip or total knee arthroplasty, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. higher scores represent a worse outcome.
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Pain Scores
Post-op 24 hour Pain Scores
|
2.5 units on a scale
Standard Deviation 2.0
|
6 units on a scale
Standard Deviation 1.4
|
|
Pain Scores
Post-op 48 hour Pain Scores
|
1.6 units on a scale
Standard Deviation 1.6
|
6.0 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Day of Surgery through post-operative day 5Investigate the number of participants that experienced post-operative complications .
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Number of Participants With Post-operative Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-operative day 5Population: We were not able to reach 1 patient for the day 5 follow-up.
This was determined by asking the subject "How satisfied were you with the NSS-Bridge Device during the time in which it was worn, with 0 being the worst and 10 being the most satisfied?"
Outcome measures
| Measure |
Intervention
n=9 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
No intervention, subject receives standard of care
|
|---|---|---|
|
Level of Comfort Wearing NSS-2 Bridge Device
|
9 units on a scale
Standard Deviation 3
|
—
|
SECONDARY outcome
Timeframe: Day of Surgery to post-op day 5Length of time from end of surgery to discharge from hospital
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Time to Hospital Discharge
|
2.1 days
Standard Deviation 2.9
|
2.2 days
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Day of Surgery through post-operative day 5Length of time from end of surgery to discharge from the recovery room
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Time to Discharge From Recovery Room
|
134.9 minutes
Standard Deviation 37.7
|
197.3 minutes
Standard Deviation 152.5
|
SECONDARY outcome
Timeframe: Day of surgery to post-op day 5Length of time from end of surgery to first oral intake
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Time to Oral Intake
|
5.3 hours
Standard Deviation 2.6
|
4.2 hours
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Day of surgery to post-op day 5Length of time from end of surgery to first ambulation
Outcome measures
| Measure |
Intervention
n=10 Participants
NSS-2-Bridge auricular therapy will be given in addition to standard of care.
NSS-2 Bridge: The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
|
Control
n=10 Participants
No intervention, subject receives standard of care
|
|---|---|---|
|
Time to Ambulation
|
11.6 hours
Standard Deviation 7.4
|
18.9 hours
Standard Deviation 6.9
|
Adverse Events
Intervention-Kidney
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control-Kidney
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place