NSS-Bridge Device for Post-Cesarean Delivery Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | March 13, 2019 |
| End Date: | May 1, 2019 |
| Contact: | Amy Monroe |
| Email: | Monroeal@upmc.edu |
| Phone: | 412-623-6382 |
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.
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.
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 antytime after
its application.
Per current standard of care, pain will be assessed in the postpartum period. At 12, 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, 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.
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 antytime after
its application.
Per current standard of care, pain will be assessed in the postpartum period. At 12, 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, 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.
Inclusion Criteria:
- Over 18 years of age
- Cesarean delivery
Exclusion Criteria:
- 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
We found this trial at
1
site
300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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