N/A
N=63
NSS-2 BRIDGE Device in Post-Operative Pain Management
Acute Pain · Surgery · Abdominal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03555266 ↗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
| Outcome | Result | p-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
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.