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

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

Official Title
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Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients

Conditions
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Post-operative Pain

Intervention / Treatment
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* Drug: Buprenorphine/Naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buprenorphine/Naloxone<br>Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed. | Drug: Buprenorphine/Naloxone<br>* 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.<br>* Other names: Suboxone;|
| No Intervention: Standard Medication Regiment<br>Subjects will take conventional intravenous or oral opioid management. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Scores | To examine changes in pain scores daily from the day of surgery to the hospital discharge day. | through study completion, an average of 6 days | 
| Postoperative Opioid Consumption | To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group. | through study completion, an average of 6 days | 
| Length of Hospital Stay | To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group. | through study completion, an average of 6 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, pain management