Trial Outcomes & Findings for NSS-Bridge Device for Post-Cesarean Delivery Pain (NCT NCT03830307)

Results Overview

Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

Day of surgery through post-operative day 5

Results posted on

2020-03-27

Participant Flow

Recruitment Period was from 3/11/2019-3/29/2019

Participant milestones

Participant milestones
Measure	Intervention Group 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Group n=5 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of surgery through post-operative day 5

Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.

Outcome measures

Outcome measures
Measure	Intervention Group n=5 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Opioid Consumption	31 milligrams of oxycodone Interval 0.0 to 60.0

SECONDARY outcome

Timeframe: Day of Surgery through 90 days post-operative

Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.

Outcome measures

Outcome measures
Measure	Intervention Group n=5 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Number of Participants With Post-operative Complications	0 Participants

SECONDARY outcome

Timeframe: Day of Surgery through 90 days post-operative

Population: 90 follow-up of opioid medication was not collected in intervention group

Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours post-operatively

Population: Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled

Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Intervention Group n=4 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Level of Comfort Wearing NSS-2 Bridge Device	1.5 score on a scale Interval 0.0 to 4.0

SECONDARY outcome

Timeframe: 48 hours post-operatively

Population: Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled

Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Intervention Group n=3 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Level of Comfort Wearing NSS-2 Bridge Device	0 score on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: 72 hours post-operatively

Population: Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled

Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Intervention Group n=3 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Level of Comfort Wearing NSS-2 Bridge Device	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 96 hours post-operatively

Population: Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled

Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.

Outcome measures

Outcome measures
Measure	Intervention Group n=2 Participants 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. NSS-2-Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care
Level of Comfort Wearing NSS-2 Bridge Device	1 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 120 hours post-operatively

Population: Some participants were unavailable to give a discomfort score on some days, hence the discrepancy of the number analyzed versus overall enrolled

Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.