NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries

NCT03834142 | Completed Results FDA Device

• 1 other identifier: STUDY19020023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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 change the incidence of post-operative opioid addiction. 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 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 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. These symptoms include pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major orthopedic surgery such as knee and hip arthroplasties. 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.

Conditions

Acute Pain; Arthropathy of Knee; Arthropathy of Hip; Pain, Postoperative; Kidney Transplant Donor; Bariatric Surgery Candidate

Keywords

Auriculotherapy; Pain Therapy

Outcome Measures

Primary Outcomes (1)

• Efficacy of NSS-2 Bridge Device in Changing Perioperative Opioid Consumption

  Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing either a total hip or total knee arthroplasty procedure, bariatric or kidney donor surgeries. Since we are comparing to historical controls, we can only analyze data from when the controls were in the hospital. This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.

  This could be within a 24hrs, 48hrs, 72 hours, 96 hours, or 120 hours timeframe.

Secondary Outcomes (7)

• Pain Scores

  Day of Surgery, 24 hours post-operative, 48 hours post-operative

• Number of Participants With Post-operative Complications

  Day of Surgery through post-operative day 5

• Level of Comfort Wearing NSS-2 Bridge Device

  Post-operative day 5

• Time to Hospital Discharge

  Day of Surgery to post-op day 5

• Time to Discharge From Recovery Room

  Day of Surgery through post-operative day 5

Study Arms (2)

Intervention

EXPERIMENTAL

NSS-2-Bridge auricular therapy will be given in addition to standard of care.

Device: NSS-2 Bridge

Control

NO INTERVENTION

No intervention, subject receives standard of care

Interventions

NSS-2 Bridge DEVICE

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Elective Total Knee OR Total Hip Arthroplasties OR Kidney transplant surgery OR Bariatric surgery

You may not qualify if:

• 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 or other implanted devices (e.g. vagal nerve simulators)
• Patients with psoriasis vulgaris diagnosis
• Women who are pregnant or breastfeeding

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (3)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Results Point of Contact

• Title: Amy Monroe
• Organization: University of Pittsburgh

monroeal@upmc.edu

412-623-6382

Study Officials

• Jacques E Chelly, MD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 10 subjects will be recruited in each surgical population (hip/knee, kidney, bariatric) to equal 30 total active participants. This will be compared to 10 controls in each surgical population, for a total of 60 participants in the entire pilot.

Study Record Dates

• First Submitted: February 6, 2019
• First Posted: February 7, 2019
• Study Start: March 8, 2019
• Primary Completion: March 30, 2021
• Study Completion: June 30, 2021
• Last Updated: August 3, 2022
• Results First Posted: August 3, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)