Trial Outcomes & Findings for BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control (NCT NCT04365465)
NCT ID: NCT04365465
Last Updated: 2023-01-18
Results Overview
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
post-operative day 3
Results posted on
2023-01-18
Participant Flow
Participant milestones
| Measure |
Active Device
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
Baseline characteristics by cohort
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 5.5 • n=93 Participants
|
32.1 years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
31.4 years
STANDARD_DEVIATION 5.8 • n=27 Participants
|
32.07 years
STANDARD_DEVIATION 0.68 • n=483 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
60 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
20 participants
n=27 Participants
|
60 participants
n=483 Participants
|
|
Education Level
High school graduate, diploma, or equivalent
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Education Level
Trade, technical, vocational training
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Education Level
Some college credit, no degree
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Education Level
Associate degree
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Education Level
Bachelor's degree
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Education Level
Master's degree
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Education Level
Doctorate degree
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Education Level
Unknown or Not Reported
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
|
Income Level
Less than $10,000
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Income Level
$10,000 to $19,999
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Income Level
$20,000 to $29,999
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Income Level
$30,000 to $39,999
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Income Level
$40,000 to $49,999
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
Income Level
$50,000 to $59,999
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Income Level
$60,000 to $69,999
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
|
Income Level
$70,000 to $79,999
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Income Level
$80,000 to $89,999
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Income Level
$90,000 to $99,999
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
Income Level
$100,000 to $149,999
|
6 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Income Level
$150,000 or more
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Income Level
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Body Mass Index
|
31.9 kg/m^2
n=93 Participants
|
29.7 kg/m^2
n=4 Participants
|
34.8 kg/m^2
n=27 Participants
|
31.9 kg/m^2
n=483 Participants
|
|
Gravidity
|
2 Number of pregnancies
n=93 Participants
|
2.5 Number of pregnancies
n=4 Participants
|
2 Number of pregnancies
n=27 Participants
|
2 Number of pregnancies
n=483 Participants
|
|
Parity
|
1 Number of offspring
n=93 Participants
|
1 Number of offspring
n=4 Participants
|
1 Number of offspring
n=27 Participants
|
1 Number of offspring
n=483 Participants
|
|
History of Anxiety/Depression
|
14 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
34 Participants
n=483 Participants
|
|
History of Mental Illness
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Prior Cesareans
|
1 Number of prior cesareans
n=93 Participants
|
1 Number of prior cesareans
n=4 Participants
|
1 Number of prior cesareans
n=27 Participants
|
1 Number of prior cesareans
n=483 Participants
|
|
Opioid Use Disorder
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Medication for Opioid Use Disorder
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Substance Use Disorder
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: post-operative day 3Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Pain Scores With Movement
|
4.57 score on a scale
Standard Error 0.231
|
4.61 score on a scale
Standard Error 0.234
|
4.19 score on a scale
Standard Error .229
|
SECONDARY outcome
Timeframe: Post-operative day 3PROMIS Pain Intensity Survey is self-reported by participants and includes the options: "Had no pain", "Mild", "Moderate", "Severe", or "Very Severe". These responses range from 1 point (had no pain) to 5 points (very severe). This means the participant raw score can be between 3 points and 15 points.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
PROMIS Pain Intensity Survey
|
8.23 score on a scale
Standard Deviation 2.04
|
7.9 score on a scale
Standard Deviation 2.05
|
7.8 score on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Post-operative day 3PROMIS Pain Interference Survey is self-reported by participants and includes the options: "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very Much". These responses range from 1 point (not at all) to 5 points (very much). This means the participant raw score can be between 3 points and 15 points.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
PROMIS Pain Interference Survey
|
9.47 score on a scale
Standard Deviation 3.52
|
9.0 score on a scale
Standard Deviation 3.42
|
9.0 score on a scale
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: Post-operative day 3Total opioid consumption as abstracted from EMR during hospital stay. The number of participants using opioids by post-operative day 3 will be recorded by binary responses of 'yes' or 'no' via EMR data.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Opioid Consumption
Opioid-free
|
8 Participants
|
4 Participants
|
6 Participants
|
|
Opioid Consumption
Used opioids
|
12 Participants
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Post-operative day 311 item survey evaluation of postoperative symptoms and independence as self reported by participants. Scale for this tool is 0-10 with 0 being "very poor" and 10 being "excellent". Total score will be calculated for each participant. Minimum score = 0 and Maximum score = 110
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
ObsQoR-11 Survey
|
79.32 score on a scale
Standard Deviation 20.85
|
76.9 score on a scale
Standard Deviation 21.47
|
80.3 score on a scale
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: First week postoperativelyICU admission as abstracted from EMR during hospital stay. This will be recorded with a binary response of 0. no or 1. yes if participant is admitted to the ICU in the first week post-op.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Recovery Variables From Med Record: ICU Admission
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First week postoperativelyReadmission as abstracted from EMR during hospital stay.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Recovery Variables From Med Record: Readmission
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First week postoperativelyReadmission due to pain issues as abstracted from EMR during hospital stay.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Recovery Variables From Med Record: Readmission Due to Pain Issues
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-operative day 31 item survey of percentage of relief experienced from pain management as self-reported by participants. Percentage options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100. Participant will self-report on post-operative day 3. Percentages will be converted to a 0-10 scale. A score of 0 (minimum value) indicates better outcomes and a score of 10 (maximum value) indicates worse outcomes
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
BPI8 Survey
|
8.5 score on a scale
Standard Deviation 1.77
|
8.3 score on a scale
Standard Deviation 2.10
|
2.9 score on a scale
Standard Deviation 2.37
|
SECONDARY outcome
Timeframe: Post-operative day 31 item survey of pain medication use frequency as self-reported by participants. Scored on a 1-5 scale, with 1 indicating better outcomes and 5 indicating worse outcomes.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
n=20 Participants
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
BPI25 Survey
|
2.91 score on a scale
Standard Deviation 0.41
|
2.93 score on a scale
Standard Deviation 0.56
|
2.93 score on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Post-Op Day 7Device tolerability will be recorded using a Visual Analogue Scale (VAS). This will be self-reported by participants. Response options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100. 0 = no pain at all and 100 = severe intolerable pain.
Outcome measures
| Measure |
Active Device
n=20 Participants
Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section.
NSS-2 Bridge: The NSS-2 BRIDGE (Appendix 1) 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.
|
Placebo Device
n=20 Participants
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section.
Inactive NSS-2 Bridge: This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
|
Active Control
Participants in this arm will receive no device, only the standard postpartum pain control.
Active control: Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
|
|---|---|---|---|
|
Device Tolerability Survey
|
76.8 VAS Score
Standard Deviation 22.1
|
80.1 VAS Score
Standard Deviation 20.0
|
—
|
Adverse Events
Active Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
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