Trial Outcomes & Findings for NSS-2 BRIDGE Device in Post-Operative Pain Management (NCT NCT03555266)
NCT ID: NCT03555266
Last Updated: 2021-11-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative
Results posted on
2021-11-01
Participant Flow
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.
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.
Participant milestones
| Measure |
NSS-2 Bridge and 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.
NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol.
|
Sham NSS-2 BRIDGE and 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 Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
NSS-2 Bridge and 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.
NSS-2 Bridge: NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol.
|
Sham NSS-2 BRIDGE and 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 Study
Protocol Violation
|
6
|
4
|
Baseline Characteristics
NSS-2 BRIDGE Device in Post-Operative Pain Management
Baseline characteristics by cohort
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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
n=53 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
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
27 participants
n=4 Participants
|
53 participants
n=27 Participants
|
|
Surgery Type
Open Procedure
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Surgery Type
Laparoscopic Procedure
|
14 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Opioid Consumption
24 Hours
|
24 oral morphine mg equivalents (OME)
Standard Deviation 27
|
38 oral morphine mg equivalents (OME)
Standard Deviation 35
|
|
Opioid Consumption
48 Hours
|
24 oral morphine mg equivalents (OME)
Standard Deviation 31
|
27 oral morphine mg equivalents (OME)
Standard Deviation 23
|
|
Opioid Consumption
72 Hours
|
13 oral morphine mg equivalents (OME)
Standard Deviation 19
|
22 oral morphine mg equivalents (OME)
Standard Deviation 26
|
|
Opioid Consumption
96 Hours
|
17 oral morphine mg equivalents (OME)
Standard Deviation 22
|
23 oral morphine mg equivalents (OME)
Standard Deviation 27
|
|
Opioid Consumption
120 Hours
|
18 oral morphine mg equivalents (OME)
Standard Deviation 23
|
23 oral morphine mg equivalents (OME)
Standard Deviation 27
|
SECONDARY outcome
Timeframe: 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operativePopulation: Patients undergoing open or laparoscopic abdominal surgical procedures.
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 |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Post-Operative Pain
24 Hours
|
4.0 scores on a scale
Standard Deviation 2.0
|
4.1 scores on a scale
Standard Deviation 2.2
|
|
Post-Operative Pain
48 Hours
|
3.0 scores on a scale
Standard Deviation 1.9
|
3.8 scores on a scale
Standard Deviation 2.3
|
|
Post-Operative Pain
72 Hours
|
2.8 scores on a scale
Standard Deviation 2.0
|
3.5 scores on a scale
Standard Deviation 2.5
|
|
Post-Operative Pain
96 Hours
|
2.9 scores on a scale
Standard Deviation 2.3
|
3.1 scores on a scale
Standard Deviation 2.4
|
|
Post-Operative Pain
120 Hours
|
2.8 scores on a scale
Standard Deviation 2.0
|
3.6 scores on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Day of surgery through post-operative day 5Population: Subjects undergoing open or laparoscopic abdominal surgical procedures
Investigate the efficacy of the NSS-2 Bridge Device in reducing perioperative consumption of non-narcotic analgesics.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Non-narcotic Analgesic Consumption
Acetaminophen
|
10840.4 milligrams
Standard Deviation 4259.29
|
10195.9 milligrams
Standard Deviation 4134.82
|
|
Non-narcotic Analgesic Consumption
Gabapentin
|
1168.4 milligrams
Standard Deviation 762.34
|
994.1 milligrams
Standard Deviation 561.77
|
|
Non-narcotic Analgesic Consumption
Ibuprofen
|
3022.2 milligrams
Standard Deviation 2136.46
|
2657.1 milligrams
Standard Deviation 1192.84
|
|
Non-narcotic Analgesic Consumption
Ketamine IV
|
197.6 milligrams
Standard Deviation 66.57
|
202.5 milligrams
Standard Deviation 49.21
|
|
Non-narcotic Analgesic Consumption
Ketorolac
|
66.3 milligrams
Standard Deviation 42.05
|
92.9 milligrams
Standard Deviation 44.34
|
SECONDARY outcome
Timeframe: Day of surgery through post-operative day 5Population: Subjects undergoing open or laparoscopic abdominal surgical procedures.
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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 Post-operative Nausea and Vomiting (PONV)
|
1.08 scores on a scale
Standard Deviation 1.70
|
1.52 scores on a scale
Standard Deviation 2.78
|
SECONDARY outcome
Timeframe: Day of surgery through recovery room discharge, up to 300 minutes post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures.
Evaluate time to recovery room discharge from out of OR time.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Length of Recovery Room Stay
|
192.3 minutes
Standard Deviation 48.1
|
207.1 minutes
Standard Deviation 84.4
|
SECONDARY outcome
Timeframe: Day of surgery through time of ambulation, up to 120 hrs post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures.
Evaluate length of time till ambulation from out of OR time.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Time to Ambulation (Walking Greater Than 15 Feet)
|
26 hours
Standard Deviation 22.60
|
24 hours
Standard Deviation 18.95
|
SECONDARY outcome
Timeframe: Day of surgery through time of first bowel movement, up to 150 hrs post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures.
Evaluate length of time till first bowel movement from out of OR time.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Time to First Bowel Movement
|
79 hours
Standard Deviation 32.63
|
62 hours
Standard Deviation 36.08
|
SECONDARY outcome
Timeframe: Day of surgery through time of oral intake, up to 160 hrs post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures.
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Time to Oral Intake
|
45 hours
Standard Deviation 41.76
|
35 hours
Standard Deviation 37.39
|
SECONDARY outcome
Timeframe: Day of surgery through discharge, up to 360 hrs post-operativePopulation: Subjects undergoing open or laparoscopic abdominal surgical procedures.
Evaluate time to hospital discharge from out of OR time.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Length of Hospital Stay
|
144 hours
Standard Deviation 48.7
|
122 hours
Standard Deviation 67.5
|
SECONDARY outcome
Timeframe: Day of Surgery through time of discharge, up to 360 hrs post-operativePopulation: Patients undergoing open or laparoscopic abdominal surgical procedures.
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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 Patient Satisfaction
|
9.36 score on a scale
Standard Deviation 1.18
|
9.39 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Day of surgery through time of discharge, up to 360 hrs post-operativePopulation: Patients undergoing open or laparoscopic abdominal surgical procedures.
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
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Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
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|---|---|---|
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Satisfaction With Pain Management
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9.45 scores on a scale
Standard Deviation 0.80
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9 scores on a scale
Standard Deviation 1.13
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SECONDARY outcome
Timeframe: Day of surgery through 90 days post-operative.Population: Patients undergoing open or laparoscopic abdominal surgical procedures.
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.
Outcome measures
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 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 ERAS protocol.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 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. 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.
|
|---|---|---|
|
Functional Recovery
Physical Component Score
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37.5 scores on a scale
Standard Deviation 8.28
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39.9 scores on a scale
Standard Deviation 10.03
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|
Functional Recovery
Mental Component Score
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55.2 scores on a scale
Standard Deviation 7.45
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52.1 scores on a scale
Standard Deviation 8.25
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Adverse Events
NSS-2 Bridge and ERAS Protocol
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham NSS-2 BRIDGE and ERAS Protocol
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 participants at risk
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.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Bowel complications
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3.8%
1/26 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
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3.7%
1/27 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
|
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Surgical and medical procedures
Surgical complications
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3.8%
1/26 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
|
0.00%
0/27 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
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Respiratory, thoracic and mediastinal disorders
Organ morbidity
|
7.7%
2/26 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
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3.7%
1/27 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
|
Other adverse events
| Measure |
NSS-2 Bridge and ERAS Protocol
n=26 participants at risk
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.
|
Sham NSS-2 BRIDGE and ERAS Protocol
n=27 participants at risk
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.
|
|---|---|---|
|
Product Issues
Device dislodgement
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0.00%
0/26 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
|
3.7%
1/27 • Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).
|
Additional Information
Jacques E. Chelly, MD, PhD, MBA
University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine
Phone: 412-623-6382
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place