Opioid UseNCT05506878
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
A study testing NSS-2 BRIDGE in people with Opioid Use and Auriculotherapy, run by Jacques E. Chelly at 4 sites in United States.
Trial summary
The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Auriculotherapy, Pain, Abdominal
- What is being tested?
- NSS-2 BRIDGE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 286 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Oct 2022to 13 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures at UPMC Shadyside Hospital, UPMC Magee-Women's Hospital, or UPMC Passavant Hospital and following the standard ERAS protocol. OR scheduled for a living-donor liver transplant surgery at UPMC Montefiore Hospital under the ERAS protocol.
- Expected hospital stay of approximately 5 days
Who cannot join
- Patients who are considered by the medical or surgical team to not be able to give consent
- Clinical evidence of anxiety, depression, including suicidal ideation. The diagnostic will be based on medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject after the subject undergoes psychosocial testing included in the protocol and that corresponding scores have been established. These tests will only be conducted after the patient has signed an informed consent form.
- Chronic pain condition that at the discretion of the PI, should exclude the subject from participating -or- chronic opioid use defined as daily use of 60 mg of oral opioid equivalent. The diagnostic will be based on the medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject.
- True allergy to all opioid medications. The diagnostic will be based on the medical history, and the determination of the symptoms associated with the recorded allergy. The PI or Co-I will be the one making the determination to enroll the subject.
- History of or current alcohol abuse (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) for at least 3 months. The PI or Co-I will be the one making the determination to enroll the subject.
- Surgical procedure performed laparoscopically
Show all 13Show fewer
- Non elective surgery
- Pregnancy
- Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
- Patients intubated with sedation, and/or receiving fentanyl infusion for sedation post-surgery.
- Rapid recovery surgeries
- Subjects with a diagnosed seizure disorder
- Use of dexmedetomidine in the ICU
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Pittsburgh Medical Center - Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
University of Pittsburgh Medical Center - Passavant Hospital
Pittsburgh, Pennsylvania, 15237
About this study
Official title: Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. Because the stimulation of the nerves of the ear by the NSS-2 BRIDGE® device (NBD®) has been shown to modulate pain pathways in rodents, decrease abdominal pain in adolescents with inflammatory bile syndrome and due to the results of our preliminary pilot study, the investigators hypothesized that this technique may also be effective in reducing the requirement for postoperative opioids and provide a non-pharmacological alternative to perioperative opioid use.
To establish the role that the stimulation of the nerves of the ear may have in reducing postoperative opioid requirement, the investigators are proposing to conduct a randomized, placebo controlled study in patients undergoing open abdominal or pelvic surgery requiring at least 5 days of hospitalization. Subjects who have signed an informed consent will be randomized in 2 groups (active NBD® group or inactive NBD® group).
Furthermore, since preoperative and postoperative mood disorders have been shown to increase postoperative pain levels and opioid requirement by up to 50%, the investigators further hypothesize that the stimulation of the ear nerves by the NSS-2 BRIDGE® effects may be in part mediated by a reduction of the level of anxiety, depression and catastrophizing as assessed using validated questionnaires.
Read the detailed description
It is established that the perioperative prescription of opioids, including doses prescribed after discharge from the hospitals, is an important contributor to the current opioid epidemic. Although many factors have been implicated including history of addiction, mood disorders and the type of surgery, the quantity and duration of opioid treatment play an important role in a patient's development of opioid use disorder (OUD). Despite recommendations by the majority of surgery and anesthesiology professionals to limit the perioperative use of opioids, and to favor the use of non-opioid analgesics, OUD remains a serious concern. Consequently, developing alternative techniques to minimize the perioperative use of opioids is critical in the fight against the current opioid epidemic.
Auriculotherapy, a form of acupuncture is an ancient technique used to treat many conditions, including pain. Its mechanism of action is believed to be primarily via the stimulation of the branches of the vagal, trigeminal, glossopharyngeal, hypogastric, facial and superficial cervical plexus nerves innervating which secondarily modulate the pain pathway and the limbic system at the level of the brainstem, spin and central nervous system. However, the use of auriculotherapy has been limited in part by the requirement for long and specific training and the lack of well-designed clinical trials demonstrating its effectiveness.
This study design is based on the high frequency of OUD following surgery for cancer and the positive results from our exploratory Institutional Review Board (IRB)- approved, randomized and placebo-controlled pilot study that assessed the effects of the NSS-2 BRIDGE® device on perioperative pain and opioid requirement in different surgical oncology models. This was a study that included subjects undergoing both open and laparoscopic procedures of different types of surgeries for abdominal cancer.
- Conditions
- Opioid Use, Auriculotherapy, Pain, Abdominal, Cancer Pain, Liver Transplant
- Being tested
- NSS-2 BRIDGE, Sham NSS-2 BRIDGE
- Keywords
- anesthesiology, auricular neurostimulation, auriculotherapy, open surgery, opioids, pain management
- Medical subject headings
- Abdominal Pain, Cancer Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSS-2 BRIDGEDevice
Also called Bridge
NBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.
Once the device is placed, subjects will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose.
Sham NSS-2 BRIDGEDevice
Also called Placebo
Sham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation.
| Study group | Role | What they receive |
|---|---|---|
| NSS-2 BRIDGE device | Active comparator | This experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days.
It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. Receives: Device: NSS-2 BRIDGE |
| Placebo Bridge | Sham comparator | The sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group. Receives: Device: Sham NSS-2 BRIDGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.
Measured: (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative
Secondary outcomes (23)
Post-operative pain rating using a numerical rating scale
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.
Measured: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Area under the curve of post-operative pain rating using a numerical rating scale
Area under the curve of 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, between 1-hour post NBD placement and day 5
Measured: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Post-operative nausea and vomiting rating
Numerical Rating Scale (NRS) nausea scores on a scale from 0-10, with 0 being no nausea, 5 being moderate nausea and 10 being the worst imaginable nausea and vomiting. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome.
Measured: 1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative
Pre-operative emotional distress related to anxiety
Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Measured: Baseline, pre-surgery
Post-operative change in emotional distress related to anxiety
Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Measured: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Measured: Baseline, pre-surgery
Post-operative change in emotional distress related to depression
Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome.
Measured: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative sleep disturbance
Pre-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Measured: Baseline, pre-surgery
Post-operative change in sleep disturbance
Post-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days.
Measured: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative pain rating using the Pain Catastrophizing Scale
Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Measured: Baseline, pre-surgery
Change in post-operative pain rating using the Pain Catastrophizing Scale
Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome
Measured: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative Brief Symptom Index Somatization Scale
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Measured: Baseline, pre-surgery
Change in the Brief Symptom Index Somatization Scale
The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely.
Measured: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Time to Oral Intake
Evaluate time to oral intake post-operative.
Measured: Day of surgery up to 5 days
Time to Ambulation
Evaluate time to ambulation, walking greater than 15 feet
Measured: Day of surgery up to 5 days
Time to discharge from the recovery unit
Evaluate the time to discharge from the recovery unit (PACU) post-operatively
Measured: Day of surgery up to 5 days
Length of hospital stay
Evaluate time to hospital discharge from out of OR time
Measured: Day of surgery up to 30 days
Device tolerability
Participants will rate on a scale of 0 to 10, 0 being completely tolerable and 10 being completely intolerable.
Measured: Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative
Overall Patient Satisfaction
Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge
Measured: Day of Surgery through discharge or post-operative day 30, whichever comes first
Total Opioid Consumption
Participant opioid consumption will be recorded using an e-Pill time cap dispenser which records the date and time at which opioids were taken.
Measured: Post-operative day 5, 1-month, and 3-months post-operative
Prescription Drug Monitoring Program (PDMP)
Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects.
Measured: Post-operative day 30
Prescription Drug Monitoring Program (PDMP)
Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects.
Measured: Post-operative day 60
Prescription Drug Monitoring Program (PDMP)
Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects.
Measured: Post-operative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start24 Oct 2022
- Primary completion13 Jan 2026
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active device versus Sham Device
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacques E. Chelly
- Sponsor type
- University, hospital or other
- Collaborators
- Masimo Corporation, National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Jacques E. Chelly, University of Pittsburgh
- Investigators
- Jacques E Chelly, MD, PhD, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05506878
- Sponsor's protocol ID
- STUDY21100077
- Other IDs
- 1R01DA054513-01A1
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2022
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: There will be annual NIH reports, and publicly sharing de-identified data with NIH.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
- ClinicalTrials.gov ID
- NCT05506878
- Acronym / sponsor ID
- STUDY21100077
- Conditions
- Opioid Use, Auriculotherapy, Pain, Abdominal, Cancer Pain, Liver Transplant
- Keywords
- anesthesiology, auricular neurostimulation, auriculotherapy, open surgery, opioids, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Jacques E. ChellyUniversity, hospital or other
- Collaborators
- Masimo Corporation, National Institute on Drug Abuse (NIDA)
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 18 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. Because the stimulation of the nerves of the ear by the NSS-2 BRIDGE® device (NBD®) has been shown to modulate pain pathways in rodents, decrease abdominal pain in adolescents with inflammatory bile syndrome and due to the results of our preliminary pilot study, the investigators hypothesized that this technique may also be effective in reducing the requirement for postoperative opioids and provide a non-pharmacological alternative to perioperative opioid use.
To establish the role that the stimulation of the nerves of the ear may have in reducing postoperative opioid requirement, the investigators are proposing to conduct a randomized, placebo controlled study in patients undergoing open abdominal or pelvic surgery requiring at least 5 days of hospitalization. Subjects who have signed an informed consent will be randomized in 2 groups (active NBD® group or inactive NBD® group).
Furthermore, since preoperative and postoperative mood disorders have been shown to increase postoperative pain levels and opioid requirement by up to 50%, the investigators further hypothesize that the stimulation of the ear nerves by the NSS-2 BRIDGE® effects may be in part mediated by a reduction of the level of anxiety, depression and catastrophizing as assessed using validated questionnaires.
Detailed description
It is established that the perioperative prescription of opioids, including doses prescribed after discharge from the hospitals, is an important contributor to the current opioid epidemic. Although many factors have been implicated including history of addiction, mood disorders and the type of surgery, the quantity and duration of opioid treatment play an important role in a patient's development of opioid use disorder (OUD). Despite recommendations by the majority of surgery and anesthesiology professionals to limit the perioperative use of opioids, and to favor the use of non-opioid analgesics, OUD remains a serious concern. Consequently, developing alternative techniques to minimize the perioperative use of opioids is critical in the fight against the current opioid epidemic.
Auriculotherapy, a form of acupuncture is an ancient technique used to treat many conditions, including pain. Its mechanism of action is believed to be primarily via the stimulation of the branches of the vagal, trigeminal, glossopharyngeal, hypogastric, facial and superficial cervical plexus nerves innervating which secondarily modulate the pain pathway and the limbic system at the level of the brainstem, spin and central nervous system. However, the use of auriculotherapy has been limited in part by the requirement for long and specific training and the lack of well-designed clinical trials demonstrating its effectiveness.
This study design is based on the high frequency of OUD following surgery for cancer and the positive results from our exploratory Institutional Review Board (IRB)- approved, randomized and placebo-controlled pilot study that assessed the effects of the NSS-2 BRIDGE® device on perioperative pain and opioid requirement in different surgical oncology models. This was a study that included subjects undergoing both open and laparoscopic procedures of different types of surgeries for abdominal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Active device versus Sham Device
| Arm | Type | Receives |
|---|---|---|
| NSS-2 BRIDGE device | Active comparator | Device: NSS-2 BRIDGEThis experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days. It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination. |
| Placebo Bridge | Sham comparator | Device: Sham NSS-2 BRIDGEThe sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years of age
- Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures at UPMC Shadyside Hospital, UPMC Magee-Women's Hospital, or UPMC Passavant Hospital and following the standard ERAS protocol. OR scheduled for a living-donor liver transplant surgery at UPMC Montefiore Hospital under the ERAS protocol.
- Expected hospital stay of approximately 5 days
Key exclusion criteria (13 listed)
- Patients who are considered by the medical or surgical team to not be able to give consent
- Clinical evidence of anxiety, depression, including suicidal ideation. The diagnostic will be based on medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject after the subject undergoes psychosocial testing included in the protocol and that corresponding scores have been established. These tests will only be conducted after the patient has signed an informed consent form.
- Chronic pain condition that at the discretion of the PI, should exclude the subject from participating -or- chronic opioid use defined as daily use of 60 mg of oral opioid equivalent. The diagnostic will be based on the medical history, the current treatment, and the clinical examination. The PI or Co-I will be the one making the determination to enroll the subject.
- True allergy to all opioid medications. The diagnostic will be based on the medical history, and the determination of the symptoms associated with the recorded allergy. The PI or Co-I will be the one making the determination to enroll the subject.
- History of or current alcohol abuse (defined as daily use of more than 1 liter of wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of illicit drugs) for at least 3 months. The PI or Co-I will be the one making the determination to enroll the subject.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NSS-2 BRIDGEAlso: BridgeNBD® will be applied to either the right or left ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation. Once the device is placed, subjects will be asked to perform a "pinch test" throughout the duration of their time wearing the device. To perform the "pinch test" subjects must pinch down on the electrodes and ground to ensure the electrodes are still placed in their designated locations and have not come loose. | Device | NSS-2 BRIDGE device |
| Sham NSS-2 BRIDGEAlso: PlaceboSham NBD® will be applied to either the left or right ear in the immediate post-operative setting (PACU). Only a trained and certified research member who has completed the necessary training required by the company will place the device. The individual placing the device will not be involved in any follow up of the subject or any data collection as that researcher will be unblinded to the treatment allocation. The patient, nurses, surgeons, and other members of the research team will all remain blinded to the treatment allocation. | Device | Placebo Bridge |
Primary outcome
Opioid Consumption
Time frame: (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative
Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery.
23 secondary outcomes
Post-operative pain rating using a numerical rating scale
Time frame: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Area under the curve of post-operative pain rating using a numerical rating scale
Time frame: 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative
Post-operative nausea and vomiting rating
Time frame: 1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative
Pre-operative emotional distress related to anxiety
Time frame: Baseline, pre-surgery
Post-operative change in emotional distress related to anxiety
Time frame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative emotional distress related to depression
Time frame: Baseline, pre-surgery
Post-operative change in emotional distress related to depression
Time frame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative sleep disturbance
Time frame: Baseline, pre-surgery
Post-operative change in sleep disturbance
Time frame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative pain rating using the Pain Catastrophizing Scale
Time frame: Baseline, pre-surgery
Change in post-operative pain rating using the Pain Catastrophizing Scale
Time frame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Pre-operative Brief Symptom Index Somatization Scale
Time frame: Baseline, pre-surgery
Change in the Brief Symptom Index Somatization Scale
Time frame: Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative
Time to Oral Intake
Time frame: Day of surgery up to 5 days
Time to Ambulation
Time frame: Day of surgery up to 5 days
Time to discharge from the recovery unit
Time frame: Day of surgery up to 5 days
Length of hospital stay
Time frame: Day of surgery up to 30 days
Device tolerability
Time frame: Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative
Overall Patient Satisfaction
Time frame: Day of Surgery through discharge or post-operative day 30, whichever comes first
Total Opioid Consumption
Time frame: Post-operative day 5, 1-month, and 3-months post-operative
Prescription Drug Monitoring Program (PDMP)
Time frame: Post-operative day 30
Prescription Drug Monitoring Program (PDMP)
Time frame: Post-operative day 60
Prescription Drug Monitoring Program (PDMP)
Time frame: Post-operative day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Yes. There will be annual NIH reports, and publicly sharing de-identified data with NIH.
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Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques E Chelly, MD, PhD, MBA principal investigator
University of Pittsburgh
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSS-2 BRIDGE in people with Opioid Use and Auriculotherapy, run by Jacques E. Chelly at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: (OME) at 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.