Opioid-use Disorder, Pain, Postoperative
Conditions
Brief 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.
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.
Interventions
DEVICENSS-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.
DEVICEInactive 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.
OTHERActive 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.
Sponsors
University of Pittsburgh
Grace Lim, MD, MS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This study is a randomized control trial with the following arms: 1) active device; 2) placebo device; 3) non-intervention (active control).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Third trimester * Cesarean delivery under neuraxial anesthesia * Healthy, clean skin * 18 years or older
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores With Movement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference Survey | Post-operative day 3 | 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. |
| Opioid Consumption | Post-operative day 3 | 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. |
| ObsQoR-11 Survey | Post-operative day 3 | 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 |
| Recovery Variables From Med Record: ICU Admission | First week postoperatively | 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. |
| PROMIS Pain Intensity Survey | Post-operative day 3 | 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. |
| Recovery Variables From Med Record: Readmission Due to Pain Issues | First week postoperatively | Readmission due to pain issues as abstracted from EMR during hospital stay. |
| BPI8 Survey | Post-operative day 3 | 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 |
| BPI25 Survey | Post-operative day 3 | 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. |
| Device Tolerability Survey | Post-Op Day 7 | 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. |
| Recovery Variables From Med Record: Readmission | First week postoperatively | Readmission as abstracted from EMR during hospital stay. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| 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. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Active Device | Placebo Device | Active Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Age, Continuous | 32.7 years STANDARD_DEVIATION 5.5 | 32.1 years STANDARD_DEVIATION 4.7 | 31.4 years STANDARD_DEVIATION 5.8 | 32.07 years STANDARD_DEVIATION 0.68 |
| Body Mass Index | 31.9 kg/m^2 | 29.7 kg/m^2 | 34.8 kg/m^2 | 31.9 kg/m^2 |
| Education Level Associate degree | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Education Level Bachelor's degree | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Education Level Doctorate degree | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Education Level High school graduate, diploma, or equivalent | 4 Participants | 1 Participants | 1 Participants | 6 Participants |
| Education Level Master's degree | 1 Participants | 5 Participants | 4 Participants | 10 Participants |
| Education Level Some college credit, no degree | 3 Participants | 3 Participants | 3 Participants | 9 Participants |
| Education Level Trade, technical, vocational training | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Education Level Unknown or Not Reported | 5 Participants | 5 Participants | 6 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 18 Participants | 17 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 2 Participants | 3 Participants |
| Gravidity | 2 Number of pregnancies | 2.5 Number of pregnancies | 2 Number of pregnancies | 2 Number of pregnancies |
| History of Anxiety/Depression | 14 Participants | 10 Participants | 10 Participants | 34 Participants |
| History of Mental Illness | 4 Participants | 3 Participants | 1 Participants | 8 Participants |
| Income Level $100,000 to $149,999 | 6 Participants | 2 Participants | 3 Participants | 11 Participants |
| Income Level $10,000 to $19,999 | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Income Level $150,000 or more | 2 Participants | 2 Participants | 5 Participants | 9 Participants |
| Income Level $20,000 to $29,999 | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Income Level $30,000 to $39,999 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Income Level $40,000 to $49,999 | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Income Level $50,000 to $59,999 | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Income Level $60,000 to $69,999 | 2 Participants | 2 Participants | 0 Participants | 4 Participants |
| Income Level $70,000 to $79,999 | 0 Participants | 2 Participants | 4 Participants | 6 Participants |
| Income Level $80,000 to $89,999 | 2 Participants | 3 Participants | 1 Participants | 6 Participants |
| Income Level $90,000 to $99,999 | 1 Participants | 4 Participants | 1 Participants | 6 Participants |
| Income Level Less than $10,000 | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Income Level Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Medication for Opioid Use Disorder | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Opioid Use Disorder | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Parity | 1 Number of offspring | 1 Number of offspring | 1 Number of offspring | 1 Number of offspring |
| Prior Cesareans | 1 Number of prior cesareans | 1 Number of prior cesareans | 1 Number of prior cesareans | 1 Number of prior cesareans |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 18 Participants | 17 Participants | 17 Participants | 52 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 60 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 20 Participants | 60 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Substance Use Disorder | 4 Participants | 1 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Pain Scores With Movement | 4.57 score on a scale | Standard Error 0.231 |
| Placebo Device | Pain Scores With Movement | 4.61 score on a scale | Standard Error 0.234 |
| Active Control | Pain Scores With Movement | 4.19 score on a scale | Standard Error 0.229 |
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.
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | BPI25 Survey | 2.91 score on a scale | Standard Deviation 0.41 |
| Placebo Device | BPI25 Survey | 2.93 score on a scale | Standard Deviation 0.56 |
| Active Control | BPI25 Survey | 2.93 score on a scale | Standard Deviation 0.56 |
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
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | BPI8 Survey | 8.5 score on a scale | Standard Deviation 1.77 |
| Placebo Device | BPI8 Survey | 8.3 score on a scale | Standard Deviation 2.1 |
| Active Control | BPI8 Survey | 2.9 score on a scale | Standard Deviation 2.37 |
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.
Time frame: Post-Op Day 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | Device Tolerability Survey | 76.8 VAS Score | Standard Deviation 22.1 |
| Placebo Device | Device Tolerability Survey | 80.1 VAS Score | Standard Deviation 20 |
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
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | ObsQoR-11 Survey | 79.32 score on a scale | Standard Deviation 20.85 |
| Placebo Device | ObsQoR-11 Survey | 76.9 score on a scale | Standard Deviation 21.47 |
| Active Control | ObsQoR-11 Survey | 80.3 score on a scale | Standard Deviation 17.9 |
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.
Time frame: Post-operative day 3
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Device | Opioid Consumption | Used opioids | 12 Participants |
| Active Device | Opioid Consumption | Opioid-free | 8 Participants |
| Placebo Device | Opioid Consumption | Opioid-free | 4 Participants |
| Placebo Device | Opioid Consumption | Used opioids | 16 Participants |
| Active Control | Opioid Consumption | Opioid-free | 6 Participants |
| Active Control | Opioid Consumption | Used opioids | 14 Participants |
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.
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | PROMIS Pain Intensity Survey | 8.23 score on a scale | Standard Deviation 2.04 |
| Placebo Device | PROMIS Pain Intensity Survey | 7.9 score on a scale | Standard Deviation 2.05 |
| Active Control | PROMIS Pain Intensity Survey | 7.8 score on a scale | Standard Deviation 1.79 |
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.
Time frame: Post-operative day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Device | PROMIS Pain Interference Survey | 9.47 score on a scale | Standard Deviation 3.52 |
| Placebo Device | PROMIS Pain Interference Survey | 9.0 score on a scale | Standard Deviation 3.42 |
| Active Control | PROMIS Pain Interference Survey | 9.0 score on a scale | Standard Deviation 3.11 |
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.
Time frame: First week postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Device | Recovery Variables From Med Record: ICU Admission | 0 Participants |
| Placebo Device | Recovery Variables From Med Record: ICU Admission | 0 Participants |
| Active Control | Recovery Variables From Med Record: ICU Admission | 0 Participants |
Secondary
Recovery Variables From Med Record: Readmission
Readmission as abstracted from EMR during hospital stay.
Time frame: First week postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Device | Recovery Variables From Med Record: Readmission | 0 Participants |
| Placebo Device | Recovery Variables From Med Record: Readmission | 0 Participants |
| Active Control | Recovery Variables From Med Record: Readmission | 0 Participants |
Secondary
Recovery Variables From Med Record: Readmission Due to Pain Issues
Readmission due to pain issues as abstracted from EMR during hospital stay.
Time frame: First week postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Device | Recovery Variables From Med Record: Readmission Due to Pain Issues | 0 Participants |
| Placebo Device | Recovery Variables From Med Record: Readmission Due to Pain Issues | 0 Participants |
| Active Control | Recovery Variables From Med Record: Readmission Due to Pain Issues | 0 Participants |