NSS-2 BRIDGE Device in Post-Operative Pain Management

NCT03555266 | Completed Results FDA Device

• 1 other identifier: NSS-2 BRIDGE
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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. Although the risk of opioid addiction following surgery is recognized, the percentage of patients becoming addicted to opioids following surgery is not well understood. 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. 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. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal. These symptoms include abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also present following major oncologic abdominal surgery. 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; Surgery; Abdominal Cancer

Keywords

Pain Therapy; Auricular Therapy

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  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.

  24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Secondary Outcomes (11)

• Post-Operative Pain

  24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

• Non-narcotic Analgesic Consumption

  Day of surgery through post-operative day 5

• Total Post-operative Nausea and Vomiting (PONV)

  Day of surgery through post-operative day 5

• Length of Recovery Room Stay

  Day of surgery through recovery room discharge, up to 300 minutes post-operative

• Time to Ambulation (Walking Greater Than 15 Feet)

  Day of surgery through time of ambulation, up to 120 hrs post-operative

Study Arms (2)

NSS-2 Bridge and ERAS Protocol

EXPERIMENTAL

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.

Device: NSS-2 Bridge

Sham NSS-2 BRIDGE and ERAS Protocol

SHAM COMPARATOR

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

Device: Sham NSS-2 BRIDGE

Interventions

NSS-2 Bridge DEVICE

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

NSS-2 Bridge and ERAS Protocol

Sham NSS-2 BRIDGE DEVICE

NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.

Sham NSS-2 BRIDGE and ERAS Protocol

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
• Major Abdominal procedure as per UPMC's Enhanced Recovery After Surgery (ERAS) anesthetic protocol

You may not qualify if:

• History of active untreated depression, anxiety or catastrophizing
• Active alcoholism or drug use
• Severe chronic condition that requires daily preoperative opioid dependence
• History of hemophilia
• Patients with cardiac pacemakers
• Patients with psoriasis vulgaris diagnosis

Sponsors & Collaborators

• Jacques E. Chelly: lead

Study Sites (1)

UPMC Shadyside Hospital

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jacques E. Chelly, MD, PhD, MBA
• Organization: University of Pittsburgh Medical Center Department of Anesthesiology and Perioperative Medicine

chelje@anes.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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The only person unblinded to treatment allocation will be the individual applying the device to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology (with Tenure) and Orthopedic Surgery

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: October 23, 2018
• Primary Completion: March 8, 2020
• Study Completion: June 30, 2021
• Last Updated: November 1, 2021
• Results First Posted: November 1, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)