Auriculo-Nerve Stimulation on Post-Operative Opioid Requirement

Launched by JACQUES E. CHELLY · Aug 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a device called the NSS-2 BRIDGE® that stimulates nerves in the ear to see if it can help reduce the need for opioids after surgery. Opioids are strong pain medications often used after operations, but they can have side effects and risks. The researchers believe that by using this device, they might provide a safer way to manage pain after surgery, especially for patients undergoing major abdominal or pelvic surgeries.

To be eligible for the trial, participants need to be adults over 18 years old and scheduled for elective surgery to remove colorectal cancer. They should expect to stay in the hospital for about five days. During the study, participants will be randomly placed into two groups: one will receive the active ear stimulation and the other will receive a placebo (a device that does not provide real stimulation). The team will also assess how mood and anxiety levels affect pain after surgery, as these factors can influence how much pain medication a person needs. If you or someone you know is facing this type of surgery, this trial could offer a new approach to pain management without relying solely on opioids.

Gender

ALL

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. 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