NCT03555266 is a NA clinical trial of NSS-2 Bridge in Acute Pain, sponsored by Jacques E. Chelly.

Who is sponsoring NCT03555266?

NCT03555266 is sponsored by Jacques E. Chelly.

What drugs are being tested in NCT03555266?

Interventions in NCT03555266: NSS-2 Bridge, Sham NSS-2 BRIDGE.

What condition does NCT03555266 study?

NCT03555266 studies Acute Pain, Surgery, Abdominal Cancer.

Is NCT03555266 still recruiting?

NCT03555266 is currently completed. Last updated 1 November 2021.

Are results published for NCT03555266?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-11-01 · How we verify

NCT03555266

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NSS-2 BRIDGE Device in Post-Operative Pain Management

Completed NA Results posted Last updated 1 November 2021

What this trial tests

NA trial testing NSS-2 Bridge in Acute Pain in 65 participants. Completed in 30 June 2021.

Timeline

23 October 2018

Primary endpoint
8 March 2020

30 June 2021

Quick facts

Lead sponsor	Jacques E. Chelly
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	65
Start date	23 October 2018
Primary completion	8 March 2020
Estimated completion	30 June 2021
Sites	1 location across United States

Drugs / interventions tested

NSS-2 Bridge
Sham NSS-2 BRIDGE

Conditions studied

Acute Pain — all drugs for Acute Pain →
Surgery — all drugs for Surgery →
Abdominal Cancer — all drugs for Abdominal Cancer →

Sponsor

Jacques E. Chelly

Who can join

18 and older, any sex, with Acute Pain or Surgery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Opioid Consumption Primary · 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

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 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	24	± 27
Sham NSS-2 BRIDGE and ERAS Protocol	38	± 35

48 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	24	± 31
Sham NSS-2 BRIDGE and ERAS Protocol	27	± 23

72 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	13	± 19
Sham NSS-2 BRIDGE and ERAS Protocol	22	± 26

96 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	17	± 22
Sham NSS-2 BRIDGE and ERAS Protocol	23	± 27

120 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	18	± 23
Sham NSS-2 BRIDGE and ERAS Protocol	23	± 27

Post-Operative Pain Secondary · 24 hrs, 48 hrs, 72 hrs, 96 hrs, and 120 hrs post-operative

Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.

24 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	4.0	± 2.0
Sham NSS-2 BRIDGE and ERAS Protocol	4.1	± 2.2

48 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	3.0	± 1.9
Sham NSS-2 BRIDGE and ERAS Protocol	3.8	± 2.3

72 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	2.8	± 2.0
Sham NSS-2 BRIDGE and ERAS Protocol	3.5	± 2.5

96 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	2.9	± 2.3
Sham NSS-2 BRIDGE and ERAS Protocol	3.1	± 2.4

120 Hours

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	2.8	± 2.0
Sham NSS-2 BRIDGE and ERAS Protocol	3.6	± 3.0

Non-narcotic Analgesic Consumption Secondary · Day of surgery through post-operative day 5

Investigate the efficacy of the NSS-2 Bridge Device in reducing perioperative consumption of non-narcotic analgesics.

Acetaminophen

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	10840.4	± 4259.29
Sham NSS-2 BRIDGE and ERAS Protocol	10195.9	± 4134.82

Gabapentin

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	1168.4	± 762.34
Sham NSS-2 BRIDGE and ERAS Protocol	994.1	± 561.77

Ibuprofen

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	3022.2	± 2136.46
Sham NSS-2 BRIDGE and ERAS Protocol	2657.1	± 1192.84

Ketamine IV

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	197.6	± 66.57
Sham NSS-2 BRIDGE and ERAS Protocol	202.5	± 49.21

Ketorolac

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	66.3	± 42.05
Sham NSS-2 BRIDGE and ERAS Protocol	92.9	± 44.34

Total Post-operative Nausea and Vomiting (PONV) Secondary · Day of surgery through post-operative day 5

Evaluate the feeling of post-operative nausea and/or vomiting during the immediate 5 day post-operative period. This will be measured on a 10-point nausea scale from 0 (no nausea) to 10 (the worst nausea imaginable). The patient reports this score on a daily basis from post-op day 1 to post-op day 5 and the five daily scores will be added to calculate a total post-operative nausea score. The lowest possible total score is 0 and the highest possible total score is 50. A higher total score represents a worse outcome.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	1.08	± 1.70
Sham NSS-2 BRIDGE and ERAS Protocol	1.52	± 2.78

Length of Recovery Room Stay Secondary · Day of surgery through recovery room discharge, up to 300 minutes post-operative

Evaluate time to recovery room discharge from out of OR time.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	192.3	± 48.1
Sham NSS-2 BRIDGE and ERAS Protocol	207.1	± 84.4

Time to Ambulation (Walking Greater Than 15 Feet) Secondary · Day of surgery through time of ambulation, up to 120 hrs post-operative

Evaluate length of time till ambulation from out of OR time.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	26	± 22.60
Sham NSS-2 BRIDGE and ERAS Protocol	24	± 18.95

Time to First Bowel Movement Secondary · Day of surgery through time of first bowel movement, up to 150 hrs post-operative

Evaluate length of time till first bowel movement from out of OR time.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	79	± 32.63
Sham NSS-2 BRIDGE and ERAS Protocol	62	± 36.08

Time to Oral Intake Secondary · Day of surgery through time of oral intake, up to 160 hrs post-operative

Evaluate length of time till oral intake from out of OR time. Time to oral intake is recorded as the first consumption of fluids, medication, or food by mouth. This is especially important for patients undergoing abdominal procedures as the time to oral intake can be delayed following such procedures.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	45	± 41.76
Sham NSS-2 BRIDGE and ERAS Protocol	35	± 37.39

Length of Hospital Stay Secondary · Day of surgery through discharge, up to 360 hrs post-operative

Evaluate time to hospital discharge from out of OR time.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	144	± 48.7
Sham NSS-2 BRIDGE and ERAS Protocol	122	± 67.5

Overall Patient Satisfaction Secondary · Day of Surgery through time of discharge, up to 360 hrs post-operative

Participants will be asked to assess their overall satisfaction with care upon discharge on a 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	9.36	± 1.18
Sham NSS-2 BRIDGE and ERAS Protocol	9.39	± 0.99

Satisfaction With Pain Management Secondary · Day of surgery through time of discharge, up to 360 hrs post-operative

Participants will be asked to assess their satisfaction with pain management upon discharge on 10-point satisfaction scale of 0 (least satisfaction) to 10 (highest satisfaction). The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a better outcome.

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	9.45	± 0.80
Sham NSS-2 BRIDGE and ERAS Protocol	9	± 1.13

Functional Recovery Secondary · Day of surgery through 90 days post-operative.

Functional recovery will be measured by the assessment of the participant's answers to the Functional Recovery Questionnaire 12-Item Short Form Health Survey (SF-12). The SF-12 Health Survey includes questions from the SF-36 Health Survey (Version 1). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The United States population average PCS-12 and MCS-12 are both 50 points. The United States population average PCS-12 and MCS-12 are both 50 points. The United States population standard deviation is 10 points. So each 10 i

Physical Component Score

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	37.5	± 8.28
Sham NSS-2 BRIDGE and ERAS Protocol	39.9	± 10.03

Mental Component Score

Group	Value	95% CI
NSS-2 Bridge and ERAS Protocol	55.2	± 7.45
Sham NSS-2 BRIDGE and ERAS Protocol	52.1	± 8.25

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for the duration of the subject's participation in the study (90 days post-operative).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NSS-2 Bridge and ERAS Protocol

Serious: 4/26 (15%)

Deaths: 0/26

Sham NSS-2 BRIDGE and ERAS Protocol

Serious: 2/27 (7%)

Deaths: 0/27

Serious adverse events (3 terms)

Reaction	System	NSS-2 Bridge and ERAS Prot…	Sham NSS-2 BRIDGE and ERAS…
Organ morbidity	Respiratory, thoracic and mediastinal disorders	—	—
Bowel complications	Gastrointestinal disorders	—	—
Surgical complications	Surgical and medical procedures	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	NSS-2 Bridge and ERAS Prot…	Sham NSS-2 BRIDGE and ERAS…
Device dislodgement	Product Issues	—	—

Most-reported serious reactions: Organ morbidity, Bowel complications, Surgical complications.

Data from ClinicalTrials.gov NCT03555266 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Neuromodulation Strategies to Reduce Inflammation and Improve Lung Complications in COVID-19 Patients.
Czura CJ, Bikson M, Charvet L, Chen JDZ, et al · · 2022 · cited 13× · PMID 35911909 · DOI 10.3389/fneur.2022.897124
Reduction in postoperative opioid requirement associated with use of the NSS-2<sup>®</sup> Bridge device, a disposable auriculo-nerve field stimulator, and factors affecting the response in cancer patients undergoing abdominal surgical procedures.
Chelly JE, Holtzman MP, Bartlett DL, Choudry HA, et al · · 2024 · PMID 40352824 · DOI 10.36266/jpmtc/119

Verify or expand the search:

Other trials of NSS-2 Bridge

Trials testing the same drug.

NCT04365465 — BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control · NA · completed
NCT03834142 — NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties, Bariatric, and Kidney Transplant Surgeries · NA · completed

Other recruiting trials for Acute Pain

Currently open trials in the same condition.

NCT06779604 — Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery · recruiting
NCT07348419 — Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery · NA · recruiting
NCT07335159 — Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention · NA · recruiting
NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp · NA · recruiting
NCT07336264 — Characterization of Acute Pain · recruiting

Other Jacques E. Chelly trials

Trials by the same sponsor.

NCT07211399 — Transition From Acute to Chronic Opioid Use and Chronic Pain · EARLY_PHASE1 · not yet recruiting
NCT06648759 — Vagal Stimulator to Reduce Nasogastric Tube Use · NA · recruiting
NCT05506878 — Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement · NA · recruiting
NCT05252858 — A Pilot Study Investigating the nCAP Signal Relief Patch in Subjects Undergoing Primary Hip or Knee Replacement Surgery · NA · completed
NCT04836936 — Auriculotherapy in the Treatment of Pre-Operative Anxiety · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03555266 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jacques E. Chelly
Last refreshed: 1 November 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03555266.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing