Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

1. Opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery

2. Undergoing orthopedic or general surgery

3. 18 years of age or older

4. Willing and able to adhere to the study protocol and follow-up schedule

5. Able to provide written informed consent to participate in the clinical trial

6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study

Exclusion Criteria:

1. Buprenorphine or buprenorphine/naloxone use in the last two weeks

2. Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia

3. Patients receiving postoperative ketamine or lidocaine boluses or infusions

4. Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control

5. Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment

6. Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function

7. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx

8. Positive pregnancy test for women of childbearing potential

9. Known allergy or sensitivity to bup/nx

10. Anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion

11. Current participation in additional pharmacologic research study

12. Active suicidal ideation as determined by PI or study clinician