NSS-2 BRIDGE Device in Post-Operative Pain Management
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2018 |
| Start Date: | October 23, 2018 |
| End Date: | December 2019 |
| Contact: | Amy Monroe |
| Email: | Monroeal@upmc.edu |
| Phone: | 412-623-6382 |
A Pilot Study Investigating the Post-Operative Analgesic Effect of NSS-2 BRIDGE Device in Subjects Undergoing Major Abdominal Oncologic Surgery: A Double-Blind, Randomized, Placebo-Controlled Trial
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 major oncologic abdominal 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 major oncologic abdominal 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.
Potential subjects (from both the prospective interventional and control groups) will be
recruited in the pre-surgical clinic of Dr. David Bartlett once they are scheduled for major
abdominal surgery. Patients will be asked for their interest in pursuing a research study
that involves wearing a percutaneous, auricular field stimulator for five days as a
supplementary method of post-operative pain control. Patients who agree to participate in the
trial will sign an IRB approved Informed Consent Form.
Once patient has signed the Informed Consent to participate in this pilot study, demographic
information and medical history will be collected from each participant on the day of
surgery. The NSS-2 BRIDGE device will be applied to the ear by Dr. Jacques Chelly or Research
Coordinator Amy Monroe in the immediate post-operative setting (PACU), as Dr. Chelly and Amy
Monroe have both completed the necessary training required by the company to apply the
device. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic
protocol, however, the patient will be made aware at the time of consent and throughout the
trial that they can drop out of the study at any time if they do not like wearing the NSS- 2
BRIDGE device.
Randomization of both groups will occur by assigning the participant a subject ID number, and
this ID number will correspond to a treatment allocation based on a pre-designed
randomization schema. This treatment allocation (intervention/control) will be contained in a
sealed, opaque, envelope with the subject ID number that is designated on envelope. The
master randomization list will be created and held by an independent data monitor who will
both create and hold the master randomization list.
The patient will be assessed 12, 24, 48, 72, 96 and 120 hours post-operatively to collect
total opioid consumption, incidence of adverse events, and level of comfort while wearing the
NSS-2 BRIDGE device. Additional data that will be collected includes total post-operative
narcotic consumption, PACU narcotic consumption, time to readiness for discharge from PACU,
time to bowel movement, time to oral intake (liquid and regular diet), time to hospital
discharge, intensive care unit (ICU) admission, readmission to the hospital, percentage of
patients readmitted because of pain related issues, overall patient satisfaction, patient
satisfaction relating 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 and pre-paid return envelope will be given to
patient to remove the device at 120 hours and send back to the hospital. The patient will be
contacted 3 months post-operatively to again assess patient satisfaction with the pain
management after surgery, and to assess functional recovery.
Post-operative nausea and/or vomiting will be evaluated by nausea score (0-10). Frequency of
emesis and rescue antiemetic requirement will be collected per the institution's standard of
care and transcribed from the medical record by research staff.
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.
Time to patient-controlled analgesia (PCA) initiation on the floor will also be measured, as
well as total PCA hydromorphone consumption over the 120-hour postoperative period.
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.
Number of patients with unsatisfactory pain relief defined as average Numerical Rating Scale
(NRS) more than 5 with or without requirement of IVPCA for pain relief during the first 120
hours postoperative period will be compared between the two groups and form the primary
outcome for the study.
Secondary outcome measures will include total post-operative narcotic consumption, PACU
narcotic consumption, time to readiness for discharge from PACU, time to bowel movement, time
to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit
(ICU) admission, readmission to the hospital, percentage of patients readmitted because of
pain related issues, overall patient satisfaction, patient satisfaction relating to pain
management, and cost analyses. 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. This patient satisfaction score will
administered by member of research team.
recruited in the pre-surgical clinic of Dr. David Bartlett once they are scheduled for major
abdominal surgery. Patients will be asked for their interest in pursuing a research study
that involves wearing a percutaneous, auricular field stimulator for five days as a
supplementary method of post-operative pain control. Patients who agree to participate in the
trial will sign an IRB approved Informed Consent Form.
Once patient has signed the Informed Consent to participate in this pilot study, demographic
information and medical history will be collected from each participant on the day of
surgery. The NSS-2 BRIDGE device will be applied to the ear by Dr. Jacques Chelly or Research
Coordinator Amy Monroe in the immediate post-operative setting (PACU), as Dr. Chelly and Amy
Monroe have both completed the necessary training required by the company to apply the
device. Rescue analgesia will be permitted as per the approved ERAS multi-modal anesthetic
protocol, however, the patient will be made aware at the time of consent and throughout the
trial that they can drop out of the study at any time if they do not like wearing the NSS- 2
BRIDGE device.
Randomization of both groups will occur by assigning the participant a subject ID number, and
this ID number will correspond to a treatment allocation based on a pre-designed
randomization schema. This treatment allocation (intervention/control) will be contained in a
sealed, opaque, envelope with the subject ID number that is designated on envelope. The
master randomization list will be created and held by an independent data monitor who will
both create and hold the master randomization list.
The patient will be assessed 12, 24, 48, 72, 96 and 120 hours post-operatively to collect
total opioid consumption, incidence of adverse events, and level of comfort while wearing the
NSS-2 BRIDGE device. Additional data that will be collected includes total post-operative
narcotic consumption, PACU narcotic consumption, time to readiness for discharge from PACU,
time to bowel movement, time to oral intake (liquid and regular diet), time to hospital
discharge, intensive care unit (ICU) admission, readmission to the hospital, percentage of
patients readmitted because of pain related issues, overall patient satisfaction, patient
satisfaction relating 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 and pre-paid return envelope will be given to
patient to remove the device at 120 hours and send back to the hospital. The patient will be
contacted 3 months post-operatively to again assess patient satisfaction with the pain
management after surgery, and to assess functional recovery.
Post-operative nausea and/or vomiting will be evaluated by nausea score (0-10). Frequency of
emesis and rescue antiemetic requirement will be collected per the institution's standard of
care and transcribed from the medical record by research staff.
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.
Time to patient-controlled analgesia (PCA) initiation on the floor will also be measured, as
well as total PCA hydromorphone consumption over the 120-hour postoperative period.
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.
Number of patients with unsatisfactory pain relief defined as average Numerical Rating Scale
(NRS) more than 5 with or without requirement of IVPCA for pain relief during the first 120
hours postoperative period will be compared between the two groups and form the primary
outcome for the study.
Secondary outcome measures will include total post-operative narcotic consumption, PACU
narcotic consumption, time to readiness for discharge from PACU, time to bowel movement, time
to oral intake (liquid and regular diet), time to hospital discharge, intensive care unit
(ICU) admission, readmission to the hospital, percentage of patients readmitted because of
pain related issues, overall patient satisfaction, patient satisfaction relating to pain
management, and cost analyses. 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. This patient satisfaction score will
administered by member of research team.
Inclusion Criteria:
- Over 18 years of age
- Major Abdominal procedure as per UPMC's Enhanced Recovery After Surgery (ERAS)
anesthetic protocol
Exclusion Criteria:
- History of active untreated depression, anxiety or catastrophizing
- Active alcoholism or drug use
- Severe chronic condition that requires daily preoperative opioid dependence
- History of hemophilia
- Patients with cardiac pacemakers
- Patients with psoriasis vulgaris diagnosis
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