Using ear nerve stimulation to reduce opioid use after surgery
Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
NA · University of Pittsburgh · NCT05506878
This study is testing whether a device that stimulates ear nerves can help reduce the need for opioids after major abdominal or pelvic surgeries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 4 sites (Pittsburgh, Pennsylvania and 3 other locations) |
| Trial ID | NCT05506878 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of the NSS-2 BRIDGE® device, which stimulates cranial nerves in the ear, in reducing the need for opioids after open abdominal or pelvic surgeries. The study is randomized and placebo-controlled, focusing on patients who are expected to stay in the hospital for at least five days post-surgery. The goal is to provide a non-pharmacological alternative to opioid pain management, addressing the growing concern of opioid use disorder following surgical procedures. The trial builds on preliminary findings that suggest auriculotherapy may help modulate pain pathways.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for elective open abdominal or pelvic colorectal cancer surgeries or living-donor liver transplants.
Not a fit: Patients with a history of anxiety, depression, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative opioid requirements, thereby minimizing the risk of opioid use disorder in patients.
How similar studies have performed: While auriculotherapy has been used historically, this specific approach using the NSS-2 BRIDGE® device is novel and has not been extensively tested in similar clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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. OR scheduled for a living-donor liver transplant surgery at UPMC Montefiore Hospital under the 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
Where this trial is running
Pittsburgh, Pennsylvania and 3 other locations
- University of Pittsburgh Medical Center - Magee-Womens Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- UPMC Montefiore Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh Medical Center - Shadyside Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
- University of Pittsburgh Medical Center - Passavant Hospital — Pittsburgh, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Jacques E Chelly, MD, PhD, MBA — University of Pittsburgh
- Study coordinator: Amy Monroe, MPH, MBA
- Email: monroeal@upmc.edu
- Phone: 412-623-6382
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Opioid Use, Auriculotherapy, Pain, Abdominal, Cancer Pain, Liver Transplant, anesthesiology, auricular neurostimulation, auriculotherapy