Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement
Opioid Use, Auriculotherapy, Pain, Abdominal
About this trial
This is an interventional treatment trial for Opioid Use focused on measuring anesthesiology, auricular neurostimulation, auriculotherapy, open surgery, opioids, pain management
Eligibility Criteria
Inclusion Criteria:
- Over 18 years of age
- Scheduled for elective open primary abdominal and pelvic colorectal cancer resection surgical procedures requiring at least 5 days at University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, Magee Woman's Hospital, or Passavant Hospital and following the standard Enhanced Recovery After Surgery (ERAS) protocol
Exclusion Criteria:
- Dementia, delirium, major anxiety, depression, catastrophizing and cognitive disorders as determined based on the medical history of the subject and their current treatment. The anxiety, depression, and catastrophizing scores will help to confirm the medical evaluation. The PI or Co-I will be the one making the determination and who will make these determinations. Subjects who's T-score on these baseline assessments is >57 will be considered to have a clinically significant diagnosis.
- Chronic pain condition or chronic opioid use defined as daily use of 60 mg of oral opioid equivalent (pain will be measured using a verbal scale, 0= no pain and 10= worst pain imaginable)
- Allergy to medication listed in the protocol (local anesthetic, opioid, and non-opioid medication)
- 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
- Contraindication or refusal of peripheral nerve block
- Surgical procedure performed laparoscopically or with an expected hospitalization lasting less than 5 days
- Non elective surgery
- Pregnancy
- Contraindication for use of NBD® (including patients with cardiac pacemaker, hemophilia, and psoriasis vulgaris diagnosis and/or ear eczema)
- History of prior abdominal surgery
Sites / Locations
- University of Pittsburgh Medical Center - Magee-Womens Hospital
- University of Pittsburgh Medical Center - Shadyside HospitalRecruiting
- University of Pittsburgh Medical Center - Passavant Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
NSS-2 BRIDGE device
Placebo Bridge
This experimental arm involves the use of the NSS-2 BRIDGE device, which is a disposable device that stimulates the branches of cranial nerves and of the superficial cervical plexus innervating the ear. It will be placed on the subject immediately after surgery and worn for 5 days. It is a percutaneous nerve field stimulator (PNFS) system, that can be used as an aid to reduce the symptoms of opioid withdrawal, through application to branches of Cranial Nerves V, VII, IX and X, and the occipital nerves identified by transillumination.
The sham group involves the use of 3 non-active points, or "nonfunctional points." The sham device will be placed on the subject immediately post-operatively and worn for 5 days just like the active group.