Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE Device for Post-Operative Pain in Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries
Phase: NA
Conditions: Acute Pain, Arthropathy of Knee, Arthropathy of Hip, Pain, Postoperative, Kidney Transplant Donor, Bariatric Surgery Candidate
Sponsor: Jacques E. Chelly

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Official Title: 
Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE 
Device for Post-Operative Pain in Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant 
Surgeries 
NCT03834142 
PI: Dr. Jacques E Chelly, MD, PhD, MBA 
Date of protocol: 09/26/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Introduction 
The current opioid epidemic has led to a renewed interest in exploring non-pharmacological 
techniques to treat post-operative pain. An increasing number of patients are suffering from the adverse 
effects of opioid use following surgery, including post-operative nausea and vomiting, respiratory 
depression, immunosuppression, constipation, and most recently, addiction. In the United States, over 
$600 billion is spent every year on opioid addiction, including $79 billion related to opioid addiction 
following surgery. Despite many initiatives to decrease the use of opiates in the preoperative setting, 
opioids continue to be regularly prescribed before, during and after surgery. Although the risk of opioid 
addiction following surgery is recognized, the percentage of patients becoming addicted to opioids 
following surgery is not well understood. To date, there has been virtually no agreement regarding the 
duration and dosage that qualify for opioid dependence following surgery, nor that a clear estimation of 
the factors such as biological, psychosocial and socioeconomic that increase the risk of using opioids for 
extended periods of time after surgery. Therefore, in order to combat this growing health crisis at the 
ground level, it is incumbent upon the medical community to explore alternative methods of pain 
control to treat the surgical population in order to reduce the incidence of post-operative opioid 
addiction.  
Project Aims/Goals 
Percutaneous Nerve Field Stimulation (PNFS) is one of these recognized methods that ongoing 
research has shown to be effective as a complementary method of pain management.   While PNFS is 
not a novel concept, clinical indications of auricular field stimulation have been limited in the past due 
to requirement of bulky, stationary and non-disposable stimulators and electrodes. These technological 
limitations made it difficult to establish the real clinical potential of auricular stimulation for the 

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perioperative management of pain in surgical patients, despite the demonstration that auriculotherapy 
has been shown to relieve pain in the postoperative setting.   
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. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to 
opioid consumption and opioid withdrawal.  The use of the NSS-2 BRIDGE device has been 
demonstrated to provide significant analgesia in patients with abdominal pain syndrome, and clinical 
trials are ongoing to assess the benefit of this approach for post-operative pain management. As 
compared to the present use of opioids for perioperative pain management, the use of a 
complementary, non-pharmacologic approach offers the advantage of analgesia without the associated 
side effects. This is especially true in the joint replacement population, where persistent opioid use 
continues to be a major public health problem.  
Mechanism of action of the Auricular Percutaneous Electrical Nerve Field 
The NSS-2 BRIDGE devise allows for stimulation to branches of Cranial Nerves V, VII, IX and X, 
and the occipital nerves, identified by transillumination. Such a stimulation is transmitted to the central 
nervous and especially the limbic system, which is known to be a key component of the central nervous 
system response to stress, anxiety and the pain pathway. The nucleus involved by the stimulation 
include the amygdala (structure involved in the response to fear and anxiety), the thalamus (structure 
involved in the management of visceral and somatic pain, addiction), the nucleus of tractus solitarie 
(structure involved in the control blood pressure) etc…. The stimulation of these nucleus produces a 
decrease in the transmission of pain impulses from visceral and/or somatic structures to supraspinal 

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areas, a reduction in anxiety and control of blood pressure and associated changes of the sympathetic 
and parasympathetic nervous system. 
The primary end point will be the frequency of patients who experience an excellent tolerability 
along with a decrease of at least 20% in pain score. Also pain score and opioid consumption will be 
compared to data obtained 20 consecutive patients (10 TKA, 10 THA) who underwent the month before.  
  Specific Aims 
Specific Aims: 
1. Tolerability and feasibility of applying the device following 10 Total Knee Arthroplasties (TKA) and 10 
Total Hip Arthroplasties (THA), 10 bariatric surgeries, and 10 kidney transplant surgeries 
2. Look at the trend of opioid consumption and pain in 20 post- THA/TKA patients wearing device, 
compared to 20 historical consecutive controls of patients who underwent THA/TKA in January 2019. 
This study has been expanded to include bariatric and kidney transplant surgeries, and will be compared 
to 10 historical controls for each group from September 2019.  
Study Design 
The proposed pilot study will be conducted as a prospective open-label trial at the University of 
Pittsburgh Medical Center (UPMC) Shadyside Hospital, Montefiore Hospital, and Magee Womens 
Hospital. For the THA/TKA arm of the study, data collected during this period will be compared to 
historical controls who have had elective THA/TKA procedures in the period of January, 2019. For the 
bariatric and kidney transplant arms of the study, data collected during this period will be compared to 
historical controls who have had bariatric/kidney transplants in September 2019.  Institutional review 
board approval will be obtained before eligible patients are recruited and consented. Trial will be 
registered at www.clinicaltrial.gov before beginning recruitment.  

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Recruitment 
For the TKA/THA arm of the study, potential subjects will be recruited in Shadyside Hospital Pre-
Operative area. The Principal Investigator, Dr. Jacques Chelly, MD, PhD, MBA will already have access to 
these patients as a member of the Acute Perioperative Pain Service (AIPPS) and patients will be 
screened the night before surgery for eligibility. Patients arrive to Shadyside Hospital three hours before 
surgery. Once they arrive, they will be asked for their interest in pursuing a research study that involves 
wearing a percutaneous, auricular field stimulator for five days as a supplementary method of post-
operative pain control after their TKA/THA surgery. Patients who agree to participate in the trial will sign 
an IRB approved Informed Consent Form. This same-day mechanism will be implemented in the kidney 
transplant arm of the study at Montefiore Hospital, with CO-I Raymond Planinsic approaching patients 
who have been screened the night before for eligibility. Dr. Planinsic will already have access to these 
patients as a hepatic anesthesiologist. For the bariatric arm of the study, the consent process will be 
initiated in the bariatric surgery clinic as the surgeon and/or clinic staff will give eligible patients who are 
interested in participating in research a copy of the NSS-2 BRIDGE information folder, which contains the 
informed consent. The patient will then be told that someone from the dept of anesthesiology's 
research team will contact them about a week before their surgery to discuss their interest in 
participating in the study. They will be given time to ask questions and discuss with their families. If the 
patient is interested in participating, they will sign the informed consent with a physician investigator on 
the day of surgery. 
Inclusion Criteria: 
 
Over 18 years of age 
Elective Total Knee and Total Hip Arthroplasties  
Bariatric Surgery 
Living-Donor Kidney Transplant surgery  

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Exclusion Criteria: 
 
History of active depression, anxiety or catastrophizing  
 
Active alcoholism or drug abuse  
 
Severe chronic pain condition that requires daily preoperative opioid dependence 
History of hemophilia 
Patients with cardiac pacemakers  
Patients with psoriasis vulgaris diagnosis 
Data Collection and Outcome Measures 
The primary purpose of this pilot study is to demonstrate feasibility/acceptability of the NSS-2 Bridge 
device applied after a THA/TKA, bariatric or kidney transplant procedure. In this pilot, no changes will be 
made in the other analgesia/postoperative care.  
Once patient has given and signed informed consent to participate in the study, demographic 
information and medical history will be collected from each participant on the day of the joint 
replacement/bariatric/kidney transplant surgery. Data will be de-identified and kept in a lock cabinet. 
The NSS-2 BRIDGE device will be applied to one ear by trained research staff in the immediate post-
operative setting. The patient will be informed at the time of consent and after the implantation of the 
device that they can have the device removed any time after its application.   
As per standard of care, at 12, 24, 48, 72, 96 and 120 hours post-operatively will be collected pain score 
at rest and movement, total opioid consumption, as well as the devise tolerability. Additionally as per 
other pain pilot IRB approved projects, we shall also collect common medical information including time 
to bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital discharge, 
intensive care unit (ICU) admission, readmission to the hospital, readmission due to pain related issues, 

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quality of recovery after joint replacement, overall patient satisfaction, and patient satisfaction related 
to pain management. When the patient is discharged from the hospital, they will be asked to complete a 
patient satisfaction survey. For patients discharged with the device attached, removal instructions will 
be given to patient to remove and dispose of the device at 120 hours.  
 
Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by the patients 
to IV morphine equivalent doses (MED) for analysis purposes. 
Overall patient satisfaction and satisfaction of pain management during hospitalization will be measured 
by a numerical rating scale with 0- worst satisfaction and 10 being the best satisfaction. The patient 
satisfaction test will be administered by a member of the research team. 
No statistical analysis will be performed. The primary end point will be the frequency of patients who 
experience an excellent tolerability along with a decrease of at least 20% in pain score. Also pain score 
and opioid consumption will be compared to data obtained from consecutive subjects who underwent a 
TKA (10) and THA (10), bariatric (10) and kidney (10) the month before. For the bariatric and kidney 
populations, this will be Sepotember, 2019.  
Pre-and-Post Metric Evaluation 
The use of a non-pharmacological NSS-2 BRIDGE has the possibility of providing analgesia to 
post-surgical patients and reducing the number of opioids required following joint 
replacement/bariatric/kidney transplant surgery. This will significantly impact patient outcomes, as 
patients will experience fewer opioid-related side effects (such as respiratory depression, post-operative 
nausea and vomiting, constipation and delirium). This will also impact clinicians caring for post-operative 
patients, as there is the real potential they will have fewer conditions to monitor and treat as the patient 
recovers from surgery. The projected number of patients served by this project will initially be 20 

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enrolled participants at Shadyside Hospital, 10 subjects at Montefiore Hospital, and 10 subjects at 
Magee Womens Hospital, however, the data collected from this trial will serve countless patients and 
the community at large as physicians strive to move away from opioid use following surgery.  Data 
collected from this pilot study will support a future proposal to the National Institute of Heath (NIH) to 
fund a full-scale, randomized, placebo-controlled trial using the NSS-2 BRIDGE device. 
Perhaps most importantly, the investigative use of the non-invasive NSS-2 BRIDGE device has 
the ability to significantly increase patient satisfaction in individuals who are opioid naïve or adverse to 
taking opioids as a method of pain control. Being able to offer the post-surgical patients within the 
UPMC hospital system such an alternative represents a great opportunity to increase patient 
satisfaction, outcomes and compliance as many patients increasingly fear the use of opioids. The NSS-2 
BRIDGE will remain effective on the participant for five days, and will have lasting effects even after 
discharge from the hospital, which is a time when many patients turn to opioids to control pain. The way 
the efficacy of this device will be measured will be by comparing total perioperative opioid consumption 
between study participants (n=20, n=10 and n=10) and historical controls who have had TKA/THA, 
kidney transplant and bariatric surgery at Shadyside, Montefiore and Magee Womens Hospital in 
January and September, 2019. Other outcome measures include the incidence of respiratory depression, 
PONV, constipation and length of stay between the study group and historical control group.    
 
 
 
 
 

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Appendix 1: NSS- 2 BRIDGE device 

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