Status:
UNKNOWN
Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Post-operative Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
Eligibility Criteria
Inclusion
- 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
- Undergoing orthopedic or general surgery
- 18 years of age or older
- Willing and able to adhere to the study protocol and follow-up schedule
- Able to provide written informed consent to participate in the clinical trial
- If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study
Exclusion
- Buprenorphine or buprenorphine/naloxone use in the last two weeks
- Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
- Patients receiving postoperative ketamine or lidocaine boluses or infusions
- Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
- Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
- Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
- Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
- Positive pregnancy test for women of childbearing potential
- Known allergy or sensitivity to bup/nx
- 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
- Current participation in additional pharmacologic research study
- Active suicidal ideation as determined by PI or study clinician
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04771689
Start Date
July 1 2022
End Date
December 1 2022
Last Update
November 4 2021
Active Locations (1)
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1
Karina de Sousa
Boston, Massachusetts, United States, 02114