Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
NCT ID: NCT04771689
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2022-07-01
2022-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Buprenorphine/Naloxone
Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.
Buprenorphine/Naloxone
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for the length of their hospital stay, at least 6 days.
Standard Medication Regiment
Subjects will take conventional intravenous or oral opioid management.
No interventions assigned to this group
Interventions
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Buprenorphine/Naloxone
Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for the length of their hospital stay, at least 6 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Yi Zhang, MD
Principal Investigator
Principal Investigators
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Yi Zhang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Karina de Sousa
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Karina de Sousa, BS
Role: primary
Grace Mogren, BS
Role: backup
Other Identifiers
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2021P000553
Identifier Type: -
Identifier Source: org_study_id