NSS-2-BRIDGE Study for Total Knee and Hip Arthroplasties
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | February 2019 |
| End Date: | March 2019 |
| Contact: | Amy Monroe |
| Email: | Monroeal@upmc.edu |
| Phone: | 412-623-6382 |
Pilot Study to Investigate the Feasibility and Tolerability of the Use of NSS-2-BRIDGE Device for Post-Operative Pain in Total Knee and Total Hip Arthroplasties
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
pain, anxiety and post-operative nausea and vomiting; conditions which are also present
following major orthopedic surgery such as knee and hip arthroplasties. 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
pain, anxiety and post-operative nausea and vomiting; conditions which are also present
following major orthopedic surgery such as knee and hip arthroplasties. 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
NSS-2 Bridge device applied after either a total hip or knee arthroplasty procedure. Is the
acceptability is confirmed, the ortho model will be included in an RFA NIH request
(RFA-NS-19-018: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
DEADLINE IS MARCH 8, 2019) for proposal related to the use of devises for reduction of opioid
use. In this pilot, no changes will be made in the other analgesia/postoperative care.
Potential subjects will be recruited in the Shadyside Hospital Pre-Operative unit when they
arrive for their total knee or hip arthroplasty. Patients will be asked if they are
interested in using the NSS-2-BRIDGE system as a way to control pain after their surgery.
They will offer to review a video explaining the mechanism of action of the NSS-2-BRIDGE
system. Subjects will be informed of the purpose of this pilot evaluation and if they agree
to participate in the trial, they will sign an IRB approved Informed Consent Form.
Once patient 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
joint replacement surgery. Data will be de-identified and kept in a lock cabinet. 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 any time after its
application.
As per standard of care, at 12, 24, 48, 72, 96 and 120 hours post-operatively pain scores
will be collected at rest and movement, total opioid consumption, as well as the devise
tolerability. Additionally, we shall collect common medical information including time to
bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital
discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due
to pain related issues, quality of recovery after joint replacement, 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- 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 will be the frequency of
patients who experience an excellent tolerability along with a decrease of at least 20% in
pain score. Also pain score and opioid consumption will be compared to data obtained from 20
historical controls who underwent a total knee arthroplasty (10) or a total hip arthroplasty
(10) the month before.
The 20 historical controls will include a medical chart review of patients who had an
elective total knee arthroplasty or total hip arthroplasty in January 2019 to specifically
look at total narcotic/non-opioid analgesic requirement, pain scores and emesis after their
surgery. Other information collected from the medical record will include age, race, and
medical history. We will also collect common medical information including time to bowel
movement, time to oral intake (liquid and regular diet), time to hospital discharge,
intensive care unit admission, readmission to the hospital, or readmission due to pain
related issues. No personal health identifiers will be collected from the historical
controls.
NSS-2 Bridge device applied after either a total hip or knee arthroplasty procedure. Is the
acceptability is confirmed, the ortho model will be included in an RFA NIH request
(RFA-NS-19-018: HEAL Initiative: Clinical Devices to Treat Pain (UH3 Clinical Trial Optional)
DEADLINE IS MARCH 8, 2019) for proposal related to the use of devises for reduction of opioid
use. In this pilot, no changes will be made in the other analgesia/postoperative care.
Potential subjects will be recruited in the Shadyside Hospital Pre-Operative unit when they
arrive for their total knee or hip arthroplasty. Patients will be asked if they are
interested in using the NSS-2-BRIDGE system as a way to control pain after their surgery.
They will offer to review a video explaining the mechanism of action of the NSS-2-BRIDGE
system. Subjects will be informed of the purpose of this pilot evaluation and if they agree
to participate in the trial, they will sign an IRB approved Informed Consent Form.
Once patient 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
joint replacement surgery. Data will be de-identified and kept in a lock cabinet. 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 any time after its
application.
As per standard of care, at 12, 24, 48, 72, 96 and 120 hours post-operatively pain scores
will be collected at rest and movement, total opioid consumption, as well as the devise
tolerability. Additionally, we shall collect common medical information including time to
bowel movement, PONV, time to oral intake (liquid and regular diet), time to hospital
discharge, intensive care unit (ICU) admission, readmission to the hospital, readmission due
to pain related issues, quality of recovery after joint replacement, 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- 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 will be the frequency of
patients who experience an excellent tolerability along with a decrease of at least 20% in
pain score. Also pain score and opioid consumption will be compared to data obtained from 20
historical controls who underwent a total knee arthroplasty (10) or a total hip arthroplasty
(10) the month before.
The 20 historical controls will include a medical chart review of patients who had an
elective total knee arthroplasty or total hip arthroplasty in January 2019 to specifically
look at total narcotic/non-opioid analgesic requirement, pain scores and emesis after their
surgery. Other information collected from the medical record will include age, race, and
medical history. We will also collect common medical information including time to bowel
movement, time to oral intake (liquid and regular diet), time to hospital discharge,
intensive care unit admission, readmission to the hospital, or readmission due to pain
related issues. No personal health identifiers will be collected from the historical
controls.
Inclusion Criteria:
- Over 18 years of age
- Elective Total Knee and Total Hip Arthroplasties
Exclusion Criteria:
- History of active depression, anxiety or catastrophizing
- Active alcoholism or drug abuse
- Severe chronic pain condition that requires daily preoperative opioid dependence
- History of hemophilia
- Patients with cardiac pacemakers
- Patients with psoriasis vulgaris diagnosis
We found this trial at
1
site
Click here to add this to my saved trials
