NSS-Bridge Device for Post-Cesarean Delivery Pain

NCT03830307 | Completed Results FDA Device

• 1 other identifier: STUDY19010299
• Study Type: interventional
• Target: 5
• 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. 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. 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 abdominal pain, anxiety and post-operative nausea and vomiting; conditions which are also present following cesarean-section 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; Cesarean Delivery

Keywords

Pain Therapy; Auriculotherapy; Cesarean Delivery

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 elective cesarean section surgery using the current post-operative standard of care.

  Day of surgery through post-operative day 5

Secondary Outcomes (17)

• Number of Participants With Post-operative Complications

  Day of Surgery through 90 days post-operative

• Efficacy of NSS-2 Bridge Device: Opioid Consumption

  Day of Surgery through 90 days post-operative

• Level of Comfort Wearing NSS-2 Bridge Device

  24 hours post-operatively

• Level of Comfort Wearing NSS-2 Bridge Device

  48 hours post-operatively

• Level of Comfort Wearing NSS-2 Bridge Device

  72 hours post-operatively

Study Arms (1)

Intervention Group

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

Interventions

NSS-2-Bridge DEVICE

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

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Over 18 years of age
• Cesarean delivery

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 use
• Current opioid maintenance therapy/use for any other reason
• History of hemophilia
• Patients with cardiac pacemakers
• Patients with psoriasis vulgaris diagnosis or other skin conditions affecting the ear

Sponsors & Collaborators

• Grace Lim, MD, MS: lead

Study Sites (1)

Magee-Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, 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: Dr. Grace Lim
• Organization: University of Pittsburgh

limkg2@upmc.edu

412-641-4260

Study Officials

• Grace Lim, MD, MS

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Obstetric Anesthesia

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: March 13, 2019
• Primary Completion: April 4, 2019
• Study Completion: April 4, 2019
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)