Opioid-use DisorderNCT04365465
BRIDGE Percutaneous Nerve Stimulation for Cesarean Delivery Pain Control
A study testing NSS-2 Bridge and Inactive NSS-2 Bridge in people with Opioid-use Disorder and Pain, Postoperative, run by Grace Lim, MD, MS at 1 site in United States.
Trial summary
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design. 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
- Opioid-use Disorder, Pain, Postoperative
- What is being tested?
- NSS-2 Bridge and Inactive NSS-2 Bridge
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2020to 30 Jun 2021
- 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
- Pregnant
- Third trimester
- Cesarean delivery under neuraxial anesthesia
- Healthy, clean skin
- 18 years or older
Who cannot join
- Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
- Unable to participate fully in all study procedures for any reason
- Cesarean delivery under general anesthesia
- History of hemophilia
- Pacemakers or implantable electronic devices
- History of psoriasis
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee Womens Hospital
Pittsburgh, Pennsylvania, 15215
About this study
Official title: BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
Read the detailed description
This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.
- Conditions
- Opioid-use Disorder, Pain, Postoperative
- Being tested
- NSS-2 Bridge, Inactive NSS-2 Bridge, Active control
- Medical subject headings
- Opioid-Related Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSS-2 BridgeDevice
The NSS-2 BRIDGE (Appendix 1) 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.
Inactive NSS-2 BridgeDevice
This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
Active controlOther
Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
| Study group | Role | What they receive |
|---|---|---|
| Active device | Experimental | Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. Receives: Device: NSS-2 Bridge |
| Placebo device | Sham comparator | Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. Receives: Device: Inactive NSS-2 Bridge |
| Active Control | Active comparator | Participants in this arm will receive no device, only the standard postpartum pain control. Receives: Other: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores 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: post-operative day 3
Secondary outcomes (10)
PROMIS Pain Intensity Survey
PROMIS Pain Intensity Survey is self-reported by participants and includes the options: "Had no pain", "Mild", "Moderate", "Severe", or "Very Severe". These responses range from 1 point (had no pain) to 5 points (very severe). This means the participant raw score can be between 3 points and 15 points.
Measured: Post-operative day 3
PROMIS Pain Interference Survey
PROMIS Pain Interference Survey is self-reported by participants and includes the options: "Not at all", "A little bit", "Somewhat", "Quite a bit", or "Very Much". These responses range from 1 point (not at all) to 5 points (very much). This means the participant raw score can be between 3 points and 15 points.
Measured: Post-operative day 3
Opioid Consumption
Total opioid consumption as abstracted from EMR during hospital stay. The number of participants using opioids by post-operative day 3 will be recorded by binary responses of 'yes' or 'no' via EMR data.
Measured: Post-operative day 3
ObsQoR-11 Survey
11 item survey evaluation of postoperative symptoms and independence as self reported by participants. Scale for this tool is 0-10 with 0 being "very poor" and 10 being "excellent". Total score will be calculated for each participant. Minimum score = 0 and Maximum score = 110
Measured: Post-operative day 3
Recovery Variables From Med Record: ICU Admission
ICU admission as abstracted from EMR during hospital stay. This will be recorded with a binary response of 0. no or 1. yes if participant is admitted to the ICU in the first week post-op.
Measured: First week postoperatively
Recovery Variables From Med Record: Readmission
Readmission as abstracted from EMR during hospital stay.
Measured: First week postoperatively
Recovery Variables From Med Record: Readmission Due to Pain Issues
Readmission due to pain issues as abstracted from EMR during hospital stay.
Measured: First week postoperatively
BPI8 Survey
1 item survey of percentage of relief experienced from pain management as self-reported by participants. Percentage options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100. Participant will self-report on post-operative day 3. Percentages will be converted to a 0-10 scale. A score of 0 (minimum value) indicates better outcomes and a score of 10 (maximum value) indicates worse outcomes
Measured: Post-operative day 3
BPI25 Survey
1 item survey of pain medication use frequency as self-reported by participants. Scored on a 1-5 scale, with 1 indicating better outcomes and 5 indicating worse outcomes.
Measured: Post-operative day 3
Device Tolerability Survey
Device tolerability will be recorded using a Visual Analogue Scale (VAS). This will be self-reported by participants. Response options: 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100. 0 = no pain at all and 100 = severe intolerable pain.
Measured: Post-Op Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start17 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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 Opioid-use DisorderStudies 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
- This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04365465
- Sponsor's protocol ID
- STUDY19110257
- Other IDs
- UL1TR001857
- Status last verified
- Dec 2022
- First submitted
- 21 Apr 2020
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRIDGE Device: Percutaneous Auricular Nerve Field Stimulation as Alternative Post-Cesarean Delivery Analgesia
- ClinicalTrials.gov ID
- NCT04365465
- Acronym / sponsor ID
- STUDY19110257
- Conditions
- Opioid-use Disorder, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Grace Lim, MD, MSUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 17 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 28 Apr 2020 (actual)
- Results
- Posted 18 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, placebo controlled and natural-history controlled trial to investigate the effectiveness of NSS-2 BRIDGE® for postpartum women with AND without opioid use disorder (OUD). The purpose of this pilot investigation is to establish feasibility/acceptability of the trial design.
Detailed description
This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control). The devices will be placed while women are still feeling pain relief from labor epidural analgesia (after delivering vaginally) or from spinal or epidural anesthesia (after delivering by cesarean). By applying the devices while women are still relatively pain-free, a preventative/pre-emptive approach to pain management in women at risk for severe postpartum pain is taken. The study will enroll women with and without OUD and follow them for five days postpartum.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
| Arm | Type | Receives |
|---|---|---|
| Active device | Experimental | Device: NSS-2 BridgeParticipants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. |
| Placebo device | Sham comparator | Device: Inactive NSS-2 BridgeParticipants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. |
| Active Control | Active comparator | Other: Active controlParticipants in this arm will receive no device, only the standard postpartum pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant
- Third trimester
- Cesarean delivery under neuraxial anesthesia
- Healthy, clean skin
- 18 years or older
Key exclusion criteria (6 listed)
- Not fluent in English (surveys are validated in English language), unable to participate in informed consent discussions, or unable to give informed consent for any reason
- Unable to participate fully in all study procedures for any reason
- Cesarean delivery under general anesthesia
- History of hemophilia
- Pacemakers or implantable electronic devices
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 BridgeThe NSS-2 BRIDGE (Appendix 1) 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. | Device | Active device |
| Inactive NSS-2 BridgeThis is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied. | Device | Placebo device |
| Active controlActive control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device. | Other | Active Control |
Primary outcome
Pain Scores With Movement
Time frame: post-operative day 3
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.
10 secondary outcomes
PROMIS Pain Intensity Survey
Time frame: Post-operative day 3
PROMIS Pain Interference Survey
Time frame: Post-operative day 3
Opioid Consumption
Time frame: Post-operative day 3
ObsQoR-11 Survey
Time frame: Post-operative day 3
Recovery Variables From Med Record: ICU Admission
Time frame: First week postoperatively
Recovery Variables From Med Record: Readmission
Time frame: First week postoperatively
Recovery Variables From Med Record: Readmission Due to Pain Issues
Time frame: First week postoperatively
BPI8 Survey
Time frame: Post-operative day 3
BPI25 Survey
Time frame: Post-operative day 3
Device Tolerability Survey
Time frame: Post-Op Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- 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
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 and Inactive NSS-2 Bridge in people with Opioid-use Disorder and Pain, Postoperative, 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 5 inclusion and 6 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 18 Jan 2023. 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. 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?
Yes. Results are posted in the registry (first posted 18 Jan 2023). 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?
Pain Scores With Movement (time frame: post-operative day 3). 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 18 Jan 2023.