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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pittsburgh | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device | Experimental | Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. |
|
| Placebo device | Sham Comparator | Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. |
|
| Active Control | Active Comparator | Participants in this arm will receive no device, only the standard postpartum pain control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NSS-2 Bridge | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | post-operative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post-operative day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Grace Lim, MD, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Magee Womens Hospital | Pittsburgh | Pennsylvania | 15215 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Device | Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. NSS-2 Bridge: 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. |
| FG001 | Placebo Device | Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. Inactive NSS-2 Bridge: 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. |
| FG002 | Active Control | Participants in this arm will receive no device, only the standard postpartum pain control. Active control: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Device | Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. NSS-2 Bridge: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | score on a scale | post-operative day 3 |
|
Active participation was from day of surgery to 1-week post-operative. During this time period, adverse events were monitored and recorded.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Device | Participants in this arm will receive an active NSS-Bridge device placed immediately following their cesarean section. NSS-2 Bridge: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace Lim, MD, MSc | UPMC Magee-Womens Hospital | 412-641-2179 | limkg2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2022 | Nov 17, 2022 | Prot_SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 24, 2021 | Dec 21, 2022 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
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Among participants who receive a device, both the participant and care providers/investigators will be blinded to whether the device is active or placebo. There is no blinding among participants who do not receive a device.
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| Inactive NSS-2 Bridge | Device | 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 control | Other | 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. |
|
| 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. | 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. | 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 | 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. | First week postoperatively |
| Recovery Variables From Med Record: Readmission | Readmission as abstracted from EMR during hospital stay. | 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. | 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 | 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. | 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. | Post-Op Day 7 |
| BG001 | Placebo Device | Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. Inactive NSS-2 Bridge: 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. |
| BG002 | Active Control | Participants in this arm will receive no device, only the standard postpartum pain control. Active control: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education Level | Count of Participants | Participants |
|
| Income Level | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Gravidity | Median | Inter-Quartile Range | Number of pregnancies |
|
| Parity | Mean | Inter-Quartile Range | Number of offspring |
|
| History of Anxiety/Depression | Count of Participants | Participants |
|
| History of Mental Illness | Count of Participants | Participants |
|
| Prior Cesareans | Median | Inter-Quartile Range | Number of prior cesareans |
|
| Opioid Use Disorder | Count of Participants | Participants |
|
| Medication for Opioid Use Disorder | Count of Participants | Participants |
|
| Substance Use Disorder | Count of Participants | Participants |
|
Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. Inactive NSS-2 Bridge: 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. |
| OG002 | Active Control | Participants in this arm will receive no device, only the standard postpartum pain control. Active control: 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 3 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Post-operative day 3 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 3 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | First week postoperatively |
|
|
|
| Secondary | Recovery Variables From Med Record: Readmission | Readmission as abstracted from EMR during hospital stay. | Posted | Count of Participants | Participants | First week postoperatively |
|
|
|
| Secondary | Recovery Variables From Med Record: Readmission Due to Pain Issues | Readmission due to pain issues as abstracted from EMR during hospital stay. | Posted | Count of Participants | Participants | First week postoperatively |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Post-operative day 3 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | VAS Score | Post-Op Day 7 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Placebo Device | Participants in this arm will receive an inactive (sham) NSS-Bridge device placed immediately following their cesarean section. Inactive NSS-2 Bridge: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Active Control | Participants in this arm will receive no device, only the standard postpartum pain control. Active control: 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |