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N/A N=5 Treatment

NSS-Bridge Device for Post-Cesarean Delivery Pain

Acute Pain · Cesarean Delivery

Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Opioid Consumption — 31 milligrams of oxycodone

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NSS-2-Bridge (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Grace Lim, MD, MS
Primary completion
Apr 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Opioid Consumption
31
SECONDARY
Number of Participants With Post-operative Complications
SECONDARY
Efficacy of NSS-2 Bridge Device: Opioid Consumption
SECONDARY
Level of Comfort Wearing NSS-2 Bridge Device
SECONDARY
Level of Comfort Wearing NSS-2 Bridge Device
SECONDARY
Level of Comfort Wearing NSS-2 Bridge Device
SECONDARY
Level of Comfort Wearing NSS-2 Bridge Device
SECONDARY
Level of Comfort Wearing NSS-2 Bridge Device
SECONDARY
Pain Score at Rest
SECONDARY
Pain Score at Rest
SECONDARY
Pain Score at Rest
SECONDARY
Pain Score at Rest
SECONDARY
Pain Score at Rest
SECONDARY
Pain Score With Movement
2
SECONDARY
Pain Score With Movement
2
SECONDARY
Pain Score With Movement
2
SECONDARY
Pain Score With Movement
2
SECONDARY
Pain Score With Movement
2

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.

Eligibility Criteria

Inclusion Criteria

  • Over 18 years of age
  • Cesarean delivery

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03830307). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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