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N/A N=63 Randomized Triple-blind Treatment

NSS-2 BRIDGE Device in Post-Operative Pain Management

Acute Pain · Surgery · Abdominal Cancer

Enrolled (actual)
63
Serious AEs
11.3%
Results posted
Nov 2021
Primary outcome: Primary: Opioid Consumption — 24; 38; 24; 27 oral morphine mg equivalents (OME)

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NSS-2 Bridge (Device); Sham NSS-2 BRIDGE (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Jacques E. Chelly
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Opioid Consumption
24; 38; 24; 27; 13; 22
SECONDARY
Post-Operative Pain
4.0; 4.1; 3.0; 3.8; 2.8; 3.5
SECONDARY
Non-narcotic Analgesic Consumption
10840.4; 10195.9; 1168.4; 994.1; 3022.2; 2657.1
SECONDARY
Total Post-operative Nausea and Vomiting (PONV)
1.08; 1.52
SECONDARY
Length of Recovery Room Stay
192.3; 207.1
SECONDARY
Time to Ambulation (Walking Greater Than 15 Feet)
26; 24
SECONDARY
Time to First Bowel Movement
79; 62
SECONDARY
Time to Oral Intake
45; 35
SECONDARY
Length of Hospital Stay
144; 122
SECONDARY
Overall Patient Satisfaction
9.36; 9.39
SECONDARY
Satisfaction With Pain Management
9.45; 9
SECONDARY
Functional Recovery
37.5; 39.9; 55.2; 52.1

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.

Eligibility Criteria

Inclusion Criteria

  • Over 18 years of age
  • Major Abdominal procedure as per UPMC's Enhanced Recovery After Surgery (ERAS) anesthetic protocol

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03555266). 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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