Opioid Use Clinical Trial
Official title:
Reduction of Opioid Requirement Associated With Auriculo-Nerve Stimulation Following Open Surgery
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.
Status | Recruiting |
Enrollment | 286 |
Est. completion date | September 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center - Magee-Womens Hospital | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Medical Center - Passavant Hospital | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Medical Center - Shadyside Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Jacques E. Chelly | Masimo Corporation, National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Consumption | Assess how the use of the NSS-2 BRIDGE Device over 5 days stimulation period affect the participant's total opioid consumption using morphine equivalent following an open abdominal or pelvic surgery. | (OME) at 24 hrs, 48 hrs, 72 hrs, 96 hrs, 120 hrs post-operative | |
Secondary | Post-operative pain rating using a numerical rating scale | Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome. | 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative | |
Secondary | Area under the curve of post-operative pain rating using a numerical rating scale | Area under the curve of Numerical Rating Scale (NRS) Pain scores on a scale from 0-10, with 0 being no pain, 5 being moderate pain and 10 being the worst imaginable pain. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome, between 1-hour post NBD placement and day 5 | 1 hour post NBD placement, days 1,2,3,4,5 post-operative, 1 month post-operative, 3 months post-operative | |
Secondary | Post-operative nausea and vomiting rating | Numerical Rating Scale (NRS) nausea scores on a scale from 0-10, with 0 being no nausea, 5 being moderate nausea and 10 being the worst imaginable nausea and vomiting. The lowest possible score is 0 and the highest possible score is 10. Higher scores represent a worse outcome. | 1 hour post NBD placement, days 1, 2, 3, 4, & 5 post-operative | |
Secondary | Pre-operative emotional distress related to anxiety | Pre-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the Patient Reported Outcome Measurement Information System (PROMIS) Emotional Distress -Anxiety- Short Form 8a questionnaire prior to surgery. There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Baseline, pre-surgery | |
Secondary | Post-operative change in emotional distress related to anxiety | Post-operative emotional distress related to anxiety will be measured by assessment of participant's answers to the PROMIS Emotional Distress -Anxiety- Short Form 8a questionnaire.There are 8 questions about how the participants may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative | |
Secondary | Pre-operative emotional distress related to depression | Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Baseline, pre-surgery | |
Secondary | Post-operative change in emotional distress related to depression | Pre-operative emotional distress related to depression will be measured by assessment of participant's answers to the PROMIS Emotional Distress-Depression-Short Form questionnaire prior to surgery. There are 8 questions about how the participant may have felt in the past 7 days. The scale for each question is from 1, never felt this way in the past 7 days, to 5, always have felt this way in the past 7 days. The overall questionnaire scores can range from 8 (least severe score) to 40 (most severe score). Higher scores present a worse outcome. | Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative | |
Secondary | Pre-operative sleep disturbance | Pre-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days. | Baseline, pre-surgery | |
Secondary | Post-operative change in sleep disturbance | Post-operative sleep disturbance will be measured by assessment of the participant's answers to the PROMIS item Bank v1.0 - Sleep Disturbance - Short Form 8a. There are 8 questions about how the participant may have felt about their sleep quality in the past 7 days. The scale for 1 question is very poor in the past 7 days to very good in the past 7 days. The scale for 7 questions is not at all in the past 7 days to very much in the past 7 days. | Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative | |
Secondary | Pre-operative pain rating using the Pain Catastrophizing Scale | Pre-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome | Baseline, pre-surgery | |
Secondary | Change in post-operative pain rating using the Pain Catastrophizing Scale | Post-operative pain ratings will be measured by the assessment of the participant's answers to the Pain Catastrophizing Scale questionnaire. There are 14 statements related to pain that participants will record experiencing on a scale of 0 being experienced not at all to 4 being experienced all of the time. The lowest possible score is 0 and the highest possible score is 56. Higher scores present a worse outcome | Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative | |
Secondary | Pre-operative Brief Symptom Index Somatization Scale | The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely. | Baseline, pre-surgery | |
Secondary | Change in the Brief Symptom Index Somatization Scale | The Brief Symptom Index Somatization Scale measures the participant's distress about 6 symptoms. There are 6 symptoms that the participant rates according to their level of stress. The symptoms include: faintness or dizziness, pains in heart or chest, nausea or upset stomach, trouble getting your breath, numbness or tingling, and feeling weak. The subject may select one of 5 responses: not at all, a little bit, moderately, quite a bit, and extremely. | Day 1, 2, 3, 4, 5, 1 month, and 3 months post-operative | |
Secondary | Time to Oral Intake | Evaluate time to oral intake post-operative. | Day of surgery up to 5 days | |
Secondary | Time to Ambulation | Evaluate time to ambulation, walking greater than 15 feet | Day of surgery up to 5 days | |
Secondary | Time to discharge from the recovery unit | Evaluate the time to discharge from the recovery unit (PACU) post-operatively | Day of surgery up to 5 days | |
Secondary | Length of hospital stay | Evaluate time to hospital discharge from out of OR time | Day of surgery up to 30 days | |
Secondary | Device tolerability | Participants will rate on a scale of 0 to 10, 0 being completely tolerable and 10 being completely intolerable. | Time of device placement, 1 hour after placement, 6, 12, 18, 24, 48, 72, 96, and 120 hours post-operative | |
Secondary | Overall Patient Satisfaction | Participants will be asked to assess their overall satisfaction upon discharge on a scale of 0 (least satisfaction) to 10 (highest satisfaction) at the time of discharge | Day of Surgery through discharge or post-operative day 30, whichever comes first | |
Secondary | Total Opioid Consumption | Participant opioid consumption will be recorded using an e-Pill time cap dispenser which records the date and time at which opioids were taken. | POD 5, 1-month, and 3-months post-operative | |
Secondary | Prescription Drug Monitoring Program (PDMP) | Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects. | POD 30 | |
Secondary | Prescription Drug Monitoring Program (PDMP) | Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects. | POD 60 | |
Secondary | Prescription Drug Monitoring Program (PDMP) | Participant PDMP will be reviewed to determine the average number of opioid refill requests by the subjects. | POD 90 |
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