NSS-2 BRIDGE Device in Post-Operative Pain Management

• ClinicalTrials.gov Identifier: NCT03555266
• Recruitment Status: Completed
• First Posted: June 13, 2018
• Results First Posted: November 1, 2021
• Last Update Posted: November 1, 2021
• Sponsor: Jacques E. Chelly
• Information provided by (Responsible Party): Jacques E. Chelly, University of Pittsburgh

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Acute Pain; Surgery; Abdominal Cancer
• Interventions: Device: NSS-2 Bridge; Device: Sham NSS-2 BRIDGE
• Enrollment: 65

Participant Flow

Recruitment Details

Patients scheduled for surgery by a member of the surgical oncology group of UPMC Shadyside hospital. Patients were recruited in the pre-surgical clinic. After obtaining a signed informed consent the patients were randomized to either an active or a placebo NSS-2 BRIDGE device®. Each patient was made aware at the time of consent and throughout the study that they could ask to have the NSS-2 BRIDGE device® removed at any time.

Pre-assignment Details

A total of 65 subjects signed an informed consent. Among them 2 were screen failures and were not randomized because the surgery was cancelled. 10 were excluded because they were considered as major protocol violations. Consequently, a total of 53 patients were included in the final analysis.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Period Title: Overall Study
Started	32	31
Completed	26	27
Not Completed	6	4
Reason Not Completed
Protocol Violation	6	4

Baseline Characteristics

Arm/Group Title		NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol	Total
Arm/Group Description		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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.	Total of all reporting groups
Overall Number of Baseline Participants		26	27	53
Baseline Analysis Population Description		Patients undergoing open or laparoscopic abdominal surgical procedures
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	14 53.8%	16 59.3%	30 56.6%
	>=65 years	12 46.2%	11 40.7%	23 43.4%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	Female	10 38.5%	17 63.0%	27 50.9%
	Male	16 61.5%	10 37.0%	26 49.1%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	1 3.8%	2 7.4%	3 5.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	24 92.3%	24 88.9%	48 90.6%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	1 3.8%	1 3.7%	2 3.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	26 participants	27 participants	53 participants
		26	27	53
Surgery Type; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	26 participants	27 participants	53 participants
	Open Procedure	12 46.2%	13 48.1%	25 47.2%
	Laparoscopic Procedure	14 53.8%	14 51.9%	28 52.8%

Outcome Measures

1. Primary Outcome

Title	Opioid Consumption
Description	Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing major abdominal surgery using the current SHY ERAS anesthesia protocol. This is reported in consumption of oral morphine mg equivalents (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative.
Time Frame	24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: oral morphine mg equivalents (OME)
24 Hours	24 (27)	38 (35)
48 Hours	24 (31)	27 (23)
72 Hours	13 (19)	22 (26)
96 Hours	17 (22)	23 (27)
120 Hours	18 (23)	23 (27)

2. Secondary Outcome

Title	Post-Operative Pain
Description	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.
Time Frame	24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Outcome Measure Data

Analysis Population Description

Patients undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: scores on a scale
24 Hours	4.0 (2.0)	4.1 (2.2)
48 Hours	3.0 (1.9)	3.8 (2.3)
72 Hours	2.8 (2.0)	3.5 (2.5)
96 Hours	2.9 (2.3)	3.1 (2.4)
120 Hours	2.8 (2.0)	3.6 (3.0)

3. Secondary Outcome

Title	Non-narcotic Analgesic Consumption
Description	Investigate the efficacy of the NSS-2 Bridge Device in reducing perioperative consumption of non-narcotic analgesics.
Time Frame	Day of surgery through post-operative day 5

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: milligrams
Acetaminophen	10840.4 (4259.29)	10195.9 (4134.82)
Gabapentin	1168.4 (762.34)	994.1 (561.77)
Ibuprofen	3022.2 (2136.46)	2657.1 (1192.84)
Ketamine IV	197.6 (66.57)	202.5 (49.21)
Ketorolac	66.3 (42.05)	92.9 (44.34)

4. Secondary Outcome

Title	Total Post-operative Nausea and Vomiting (PONV)
Description	Evaluate the feeling of post-operative nausea and/or vomiting during the immediate 5 day post-operative period. This will be measured on a 10-point nausea scale from 0 (no nausea) to 10 (the worst nausea imaginable). The patient reports this score on a daily basis from post-op day 1 to post-op day 5 and the five daily scores will be added to calculate a total post-operative nausea score. The lowest possible total score is 0 and the highest possible total score is 50. A higher total score represents a worse outcome.
Time Frame	Day of surgery through post-operative day 5

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: scores on a scale
	1.08 (1.70)	1.52 (2.78)

5. Secondary Outcome

Title	Length of Recovery Room Stay
Description	Evaluate time to recovery room discharge from out of OR time.
Time Frame	Day of surgery through recovery room discharge, up to 300 minutes post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: minutes
	192.3 (48.1)	207.1 (84.4)

6. Secondary Outcome

Title	Time to Ambulation (Walking Greater Than 15 Feet)
Description	Evaluate length of time till ambulation from out of OR time.
Time Frame	Day of surgery through time of ambulation, up to 120 hrs post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: hours
	26 (22.60)	24 (18.95)

7. Secondary Outcome

Title	Time to First Bowel Movement
Description	Evaluate length of time till first bowel movement from out of OR time.
Time Frame	Day of surgery through time of first bowel movement, up to 150 hrs post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: hours
	79 (32.63)	62 (36.08)

8. Secondary Outcome

Title	Time to Oral Intake
Description	Evaluate length of time till oral intake from out of OR time. Time to oral intake is recorded as the first consumption of fluids, medication, or food by mouth. This is especially important for patients undergoing abdominal procedures as the time to oral intake can be delayed following such procedures.
Time Frame	Day of surgery through time of oral intake, up to 160 hrs post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: hours
	45 (41.76)	35 (37.39)

9. Secondary Outcome

Title	Length of Hospital Stay
Description	Evaluate time to hospital discharge from out of OR time.
Time Frame	Day of surgery through discharge, up to 360 hrs post-operative

Outcome Measure Data

Analysis Population Description

Subjects undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: hours
	144 (48.7)	122 (67.5)

10. Secondary Outcome

Title	Overall Patient Satisfaction
Description	Participants will be asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Time Frame	Day of Surgery through time of discharge, up to 360 hrs post-operative

Outcome Measure Data

Analysis Population Description

Patients undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: score on a scale
	9.36 (1.18)	9.39 (0.99)

11. Secondary Outcome

Title	Satisfaction With Pain Management
Description	Participants will be asked to assess their satisfaction with pain management upon discharge on 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.
Time Frame	Day of surgery through time of discharge, up to 360 hrs post-operative

Outcome Measure Data

Analysis Population Description

Patients undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: scores on a scale
	9.45 (0.80)	9 (1.13)

12. Secondary Outcome

Title	Functional Recovery
Description	Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average. The highest possible PCS-12 score is 56.57706 and the lowest possible score is 23.99938. The highest possible MCS-12 score is 60.75781 and the lowest possible score is 19.06444. Higher scores for both represent better functioning.
Time Frame	Day of surgery through 90 days post-operative.

Outcome Measure Data

Analysis Population Description

Patients undergoing open or laparoscopic abdominal surgical procedures.

Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description:	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
Overall Number of Participants Analyzed	26	27
Mean (Standard Deviation); Unit of Measure: scores on a scale
Physical Component Score	37.5 (8.28)	39.9 (10.03)
Mental Component Score	55.2 (7.45)	52.1 (8.25)

Adverse Events

Time Frame	Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
Arm/Group Description	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 ERAS protocol.	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. This arm will contain an inactive sham NSS-2 BRIDGE device plus standard of care for abdominal oncological surgeries. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic protocol Sham NSS-2 BRIDGE: NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
All-Cause Mortality
	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/26 (0.00%)	0/27 (0.00%)
Serious Adverse Events
	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
	Affected / at Risk (%)	Affected / at Risk (%)
Total	4/26 (15.38%)	2/27 (7.41%)
Gastrointestinal disorders
Bowel complications †	1/26 (3.85%)	1/27 (3.70%)
Respiratory, thoracic and mediastinal disorders
Organ morbidity †	2/26 (7.69%)	1/27 (3.70%)
Surgical and medical procedures
Surgical complications †	1/26 (3.85%)	0/27 (0.00%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	NSS-2 Bridge and ERAS Protocol	Sham NSS-2 BRIDGE and ERAS Protocol
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/26 (0.00%)	1/27 (3.70%)
Product Issues
Device dislodgement †	0/26 (0.00%)	1/27 (3.70%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Jacques E. Chelly, MD, PhD, MBA
• Organization: University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine
• Phone: 412-623-6382
• EMail: chelje@anes.upmc.edu

• Responsible Party: Jacques E. Chelly, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT03555266
• Other Study ID Numbers: NSS-2 BRIDGE
• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Results First Submitted: August 2, 2021
• Results First Posted: November 1, 2021
• Last Update Posted: November 1, 2021