Acute PainNCT03830307
NSS-Bridge Device for Post-Cesarean Delivery Pain
A study testing NSS-2-Bridge in people with Acute Pain and Cesarean Delivery, run by Grace Lim, MD, MS at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Cesarean Delivery
- What is being tested?
- NSS-2-Bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2019to 4 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Cesarean delivery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Open-Label Application of the NSS-Bridge Device for Post-Cesarean Pain
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.
Read the detailed description
The primary purpose of this pilot study is to demonstrate feasibility/acceptability of the BRIDGE device as applied after cesarean delivery. Once the feasibility/acceptability is confirmed, the cesarean delivery model will be included in an NIH application related to the use of devices to reduce opioid use. In this pilot period, no changes will be made in the other routine analgesia/postpartum care. Following the same previously published approaches from our group, potential subjects will be recruited in the Magee-Womens Hospital obstetrical unit when they arrive for cesarean delivery. Patients will be asked if they are interested in using the BRIDGE system as a way to control pain after the cesarean delivery. They will be offered the option to review a video explaining the mechanism of action if the BRIDGE system. They will also be provided with information about the acceptability of the BRIDGE device in other clinical settings. Subjects will be informed of the purpose of this pilot evaluation and signed written informed consent to participate in the study.
Once the subject has given and signed informed consent to participate in the study, demographic information and medical history will be collected from each participant on the day of the cesarean delivery. Data will be de-identified and kept in a locked cabinet and secured servers. The NSS-2 BRIDGE device will be applied to one ear by trained research staff in the immediate post-operative setting. The patient will be informed at the time of consent and after the implantation of the device that they can have the device removed anytime after its application.
Per current standard of care, pain will be assessed in the postpartum period. At 24, 48, 72, 96 and 120 hours post-operatively the investigators will collected pain scores at rest and movement, pain unpleasantness, total opioid consumption (from the medical record), as well as the devise tolerability.
The investigators will also collect common medical information including time to bowel movement, postoperative nausea and vomiting (PONV), time to oral intake (liquid and regular diet), time to hospital discharge, overall patient satisfaction, and patient satisfaction related to pain management. When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. For patients discharged with the device attached, removal instructions will be given to patient to remove and dispose of the device at 120 hours.
Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by the patients to IV morphine equivalent doses (MED) for analysis purposes.
Overall patient satisfaction and satisfaction of pain management during hospitalization will be measured by a numerical rating scale with 0 being worst satisfaction and 10 being the best satisfaction. The patient satisfaction test will be administered by a member of the research team.
No statistical analysis will be performed. The primary end point for this pilot phase will be the descriptive feasibility and acceptability of the use of this device un cesarean delivery population. We will assess the experience of device tolerability along with pain intensity. Pain intensity scores and opioid consumption will be compared to data obtained from historical data of women undergoing cesarean delivery.
- Conditions
- Acute Pain, Cesarean Delivery
- Being tested
- NSS-2-Bridge
- Keywords
- Pain Therapy, Auriculotherapy, Cesarean Delivery
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSS-2-BridgeDevice
NSS-2-Bridge auricular therapy will be given in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Device: NSS-2-Bridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.
Measured: Day of surgery through post-operative day 5
Secondary outcomes (17)
Number of Participants With Post-operative Complications
Investigate the incidence of post-operative complications for patients receiving the NSS-2-Bridge device.
Measured: Day of Surgery through 90 days post-operative
Efficacy of NSS-2 Bridge Device: Opioid Consumption
Investigate the efficacy of the NSS-2 BRIDGE device in changing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery.
Measured: Day of Surgery through 90 days post-operative
Level of Comfort Wearing NSS-2 Bridge Device
Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 24 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 48 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 72 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 96 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Level of comfort while wearing device will be evaluated by a score on a scale (0- no discomfort 10- worst discomfort). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 120 hours post-operatively
Pain Score at Rest
Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 24 hours post-operatively
Pain Score at Rest
Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 48 hours post-operatively
Pain Score at Rest
Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 72 hours post-operatively
Pain Score at Rest
Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 96 hours post-operatively
Pain Score at Rest
=Pain Score at rest will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 120 hours post-operatively
Pain Score With Movement
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 24 hours post-operatively
Pain Score With Movement
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 48 hours post-operatively
Pain Score With Movement
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 72 hours post-operatively
Pain Score With Movement
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 96 hours post-operatively
Pain Score With Movement
Pain Score with movement will be measured by a score on a scale (0=no pain 10=most pain). The minimum value is 0 and the maximum value is 10. Higher scores mean a worse outcome.
Measured: 120 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start13 Mar 2019
- Primary completion4 Apr 2019
- Study completion4 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute PainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD, MS, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830307
- Sponsor's protocol ID
- STUDY19010299
- Status last verified
- Mar 2020
- First submitted
- 1 Feb 2019
- Last updated
- 27 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Application of the NSS-Bridge Device for Post-Cesarean Pain
- ClinicalTrials.gov ID
- NCT03830307
- Acronym / sponsor ID
- STUDY19010299
- Conditions
- Acute Pain, Cesarean Delivery
- Keywords
- Pain Therapy, Auriculotherapy, Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Grace Lim, MD, MSUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 4 Apr 2019 (actual)
- Study completion
- 4 Apr 2019 (actual)
- First posted
- 5 Feb 2019 (actual)
- Results
- Posted 27 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary purpose of this pilot study is to demonstrate feasibility/acceptability of the BRIDGE device as applied after cesarean delivery. Once the feasibility/acceptability is confirmed, the cesarean delivery model will be included in an NIH application related to the use of devices to reduce opioid use. In this pilot period, no changes will be made in the other routine analgesia/postpartum care. Following the same previously published approaches from our group, potential subjects will be recruited in the Magee-Womens Hospital obstetrical unit when they arrive for cesarean delivery. Patients will be asked if they are interested in using the BRIDGE system as a way to control pain after the cesarean delivery. They will be offered the option to review a video explaining the mechanism of action if the BRIDGE system. They will also be provided with information about the acceptability of the BRIDGE device in other clinical settings. Subjects will be informed of the purpose of this pilot evaluation and signed written informed consent to participate in the study.
Once the subject has given and signed informed consent to participate in the study, demographic information and medical history will be collected from each participant on the day of the cesarean delivery. Data will be de-identified and kept in a locked cabinet and secured servers. The NSS-2 BRIDGE device will be applied to one ear by trained research staff in the immediate post-operative setting. The patient will be informed at the time of consent and after the implantation of the device that they can have the device removed anytime after its application.
Per current standard of care, pain will be assessed in the postpartum period. At 24, 48, 72, 96 and 120 hours post-operatively the investigators will collected pain scores at rest and movement, pain unpleasantness, total opioid consumption (from the medical record), as well as the devise tolerability.
The investigators will also collect common medical information including time to bowel movement, postoperative nausea and vomiting (PONV), time to oral intake (liquid and regular diet), time to hospital discharge, overall patient satisfaction, and patient satisfaction related to pain management. When the patient is discharged from the hospital, they will be asked to complete a patient satisfaction survey. For patients discharged with the device attached, removal instructions will be given to patient to remove and dispose of the device at 120 hours.
Standard opioid conversion table will be used to convert the oral and IV narcotic utilized by the patients to IV morphine equivalent doses (MED) for analysis purposes.
Overall patient satisfaction and satisfaction of pain management during hospitalization will be measured by a numerical rating scale with 0 being worst satisfaction and 10 being the best satisfaction. The patient satisfaction test will be administered by a member of the research team.
No statistical analysis will be performed. The primary end point for this pilot phase will be the descriptive feasibility and acceptability of the use of this device un cesarean delivery population. We will assess the experience of device tolerability along with pain intensity. Pain intensity scores and opioid consumption will be compared to data obtained from historical data of women undergoing cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: NSS-2-BridgeThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age
- Cesarean delivery
Key exclusion criteria (7 listed)
- 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
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-BridgeNSS-2-Bridge auricular therapy will be given in addition to standard of care | Device | Intervention Group |
Primary outcome
Opioid Consumption
Time frame: Day of surgery through post-operative day 5
Investigate the efficacy of the NSS-2 BRIDGE device in reducing perioperative opioid consumption in opioid-naïve patients undergoing elective cesarean section surgery using the current post-operative standard of care.
17 secondary outcomes
Number of Participants With Post-operative Complications
Time frame: Day of Surgery through 90 days post-operative
Efficacy of NSS-2 Bridge Device: Opioid Consumption
Time frame: Day of Surgery through 90 days post-operative
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: 24 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: 48 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: 72 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: 96 hours post-operatively
Level of Comfort Wearing NSS-2 Bridge Device
Time frame: 120 hours post-operatively
Pain Score at Rest
Time frame: 24 hours post-operatively
Pain Score at Rest
Time frame: 48 hours post-operatively
Pain Score at Rest
Time frame: 72 hours post-operatively
Pain Score at Rest
Time frame: 96 hours post-operatively
Pain Score at Rest
Time frame: 120 hours post-operatively
Pain Score With Movement
Time frame: 24 hours post-operatively
Pain Score With Movement
Time frame: 48 hours post-operatively
Pain Score With Movement
Time frame: 72 hours post-operatively
Pain Score With Movement
Time frame: 96 hours post-operatively
Pain Score With Movement
Time frame: 120 hours post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Grace Lim, MD, MS principal investigator
University of Pittsburgh Medical Center
1 site 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 Acute Pain and Cesarean Delivery, run by Grace Lim, MD, MS at 1 site 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 2 inclusion and 7 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 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Day of surgery through post-operative day 5). 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 27 Mar 2020.