Trial Title:
Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
NCT ID:
NCT05506878
Condition:
Opioid Use
Auriculotherapy
Pain, Abdominal
Cancer Pain
Conditions: Official terms:
Cancer Pain
Abdominal Pain
Conditions: Keywords:
anesthesiology
auricular neurostimulation
auriculotherapy
open surgery
opioids
pain management
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Active device versus Sham Device
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
3 researchers have been appointed to randomization and are not participating in any part
of the study other than treatment allocation. The researcher applying the device will not
know the treatment allocation, and everyone else (participant, care provider,
investigator and outcomes assessor) will be blinded to treatment allocation as well.
Intervention:
Intervention type:
Device
Intervention name:
NSS-2 BRIDGE
Description:
NBD® will be applied to either the right or left ear in the immediate post-operative
setting (PACU). Only a trained and certified research member who has completed the
necessary training required by the company will place the device. The individual placing
the device will not be involved in any follow up of the subject or any data collection as
that researcher will be unblinded to the treatment allocation. The patient, nurses,
surgeons, and other members of the research team will all remain blinded to the treatment
allocation.
Once the device is placed, subjects will be asked to perform a "pinch test" throughout
the duration of their time wearing the device. To perform the "pinch test" subjects must
pinch down on the electrodes and ground to ensure the electrodes are still placed in
their designated locations and have not come loose.
Arm group label:
NSS-2 BRIDGE device
Other name:
Bridge
Intervention type:
Device
Intervention name:
Sham NSS-2 BRIDGE
Description:
Sham NBD® will be applied to either the left or right ear in the immediate post-operative
setting (PACU). Only a trained and certified research member who has completed the
necessary training required by the company will place the device. The individual placing
the device will not be involved in any follow up of the subject or any data collection as
that researcher will be unblinded to the treatment allocation. The patient, nurses,
surgeons, and other members of the research team will all remain blinded to the treatment
allocation.
Arm group label:
Placebo Bridge
Other name:
Placebo
Summary:
The NSS-2 BRIDGE® device (NSS stands for Neuro-Stimulation System) is a disposable device
that stimulates the branches of cranial nerves and of the superficial cervical plexus
innervating the ear. Because the stimulation of the nerves of the ear by the NSS-2
BRIDGE® device (NBD®) has been shown to modulate pain pathways in rodents, decrease
abdominal pain in adolescents with inflammatory bile syndrome and due to the results of
our preliminary pilot study, the investigators hypothesized that this technique may also
be effective in reducing the requirement for postoperative opioids and provide a
non-pharmacological alternative to perioperative opioid use.
To establish the role that the stimulation of the nerves of the ear may have in reducing
postoperative opioid requirement, the investigators are proposing to conduct a
randomized, placebo controlled study in patients undergoing open abdominal or pelvic
surgery requiring at least 5 days of hospitalization. Subjects who have signed an
informed consent will be randomized in 2 groups (active NBD® group or inactive NBD®
group).
Furthermore, since preoperative and postoperative mood disorders have been shown to
increase postoperative pain levels and opioid requirement by up to 50%, the investigators
further hypothesize that the stimulation of the ear nerves by the NSS-2 BRIDGE® effects
may be in part mediated by a reduction of the level of anxiety, depression and
catastrophizing as assessed using validated questionnaires.
Detailed description:
It is established that the perioperative prescription of opioids, including doses
prescribed after discharge from the hospitals, is an important contributor to the current
opioid epidemic. Although many factors have been implicated including history of
addiction, mood disorders and the type of surgery, the quantity and duration of opioid
treatment play an important role in a patient's development of opioid use disorder (OUD).
Despite recommendations by the majority of surgery and anesthesiology professionals to
limit the perioperative use of opioids, and to favor the use of non-opioid analgesics,
OUD remains a serious concern. Consequently, developing alternative techniques to
minimize the perioperative use of opioids is critical in the fight against the current
opioid epidemic.
Auriculotherapy, a form of acupuncture is an ancient technique used to treat many
conditions, including pain. Its mechanism of action is believed to be primarily via the
stimulation of the branches of the vagal, trigeminal, glossopharyngeal, hypogastric,
facial and superficial cervical plexus nerves innervating which secondarily modulate the
pain pathway and the limbic system at the level of the brainstem, spin and central
nervous system. However, the use of auriculotherapy has been limited in part by the
requirement for long and specific training and the lack of well-designed clinical trials
demonstrating its effectiveness.
This study design is based on the high frequency of OUD following surgery for cancer and
the positive results from our exploratory Institutional Review Board (IRB)- approved,
randomized and placebo-controlled pilot study that assessed the effects of the NSS-2
BRIDGE® device on perioperative pain and opioid requirement in different surgical
oncology models. This was a study that included subjects undergoing both open and
laparoscopic procedures of different types of surgeries for abdominal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Over 18 years of age
2. Scheduled for elective open primary abdominal and pelvic colorectal cancer resection
surgical procedures at UPMC Shadyside Hospital, UPMC Magee-Women's Hospital, or UPMC
Passavant Hospital and following the standard ERAS protocol
3. Expected hospital stay of approximately 5 days
Exclusion Criteria:
1. Patients who are considered by the medical or surgical team to not be able to give
consent
2. Clinical evidence of anxiety, depression, including suicidal ideation. The
diagnostic will be based on medical history, the current treatment, and the clinical
examination. The PI or Co-I will be the one making the determination to enroll the
subject after the subject undergoes psychosocial testing included in the protocol
and that corresponding scores have been established. These tests will only be
conducted after the patient has signed an informed consent form.
3. Chronic pain condition that at the discretion of the PI, should exclude the subject
from participating -or- chronic opioid use defined as daily use of 60 mg of oral
opioid equivalent. The diagnostic will be based on the medical history, the current
treatment, and the clinical examination. The PI or Co-I will be the one making the
determination to enroll the subject.
4. True allergy to all opioid medications. The diagnostic will be based on the medical
history, and the determination of the symptoms associated with the recorded allergy.
The PI or Co-I will be the one making the determination to enroll the subject.
5. History of or current alcohol abuse (defined as daily use of more than 1 liter of
wine and/or 3 or more shots of hard liquor) or drug abuse (defined as daily use of
illicit drugs) for at least 3 months. The PI or Co-I will be the one making the
determination to enroll the subject.
6. Surgical procedure performed laparoscopically
7. Non elective surgery
8. Pregnancy
9. Contraindication for use of NBD® (including patients with cardiac pacemaker,
hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
10. Patients intubated with sedation, and/or receiving fentanyl infusion for sedation
post-surgery.
11. Rapid recovery surgeries
12. Subjects with a diagnosed seizure disorder
13. Use of dexmedetomidine in the ICU
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pittsburgh Medical Center - Magee-Womens Hospital
Address:
City:
Pittsburgh
Zip:
15213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Grace K Lim, MD, MS
Email:
limgk2@upmc.edu
Facility:
Name:
University of Pittsburgh Medical Center - Shadyside Hospital
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jacques E Chelly, MD, PhD, MBA
Phone:
412-623-6904
Email:
chelje@anes.upmc.edu
Facility:
Name:
University of Pittsburgh Medical Center - Passavant Hospital
Address:
City:
Pittsburgh
Zip:
15237
Country:
United States
Status:
Recruiting
Contact:
Last name:
Charles Lin, MD
Email:
linc4@upmc.edu
Start date:
October 24, 2022
Completion date:
September 30, 2026
Lead sponsor:
Agency:
Jacques E. Chelly
Agency class:
Other
Collaborator:
Agency:
Masimo Corporation
Agency class:
Industry
Collaborator:
Agency:
National Institute on Drug Abuse (NIDA)
Agency class:
NIH
Source:
University of Pittsburgh
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05506878
