Post-operative Pain
Conditions
Keywords
pain, pain management
Brief summary
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
Interventions
DRUGBuprenorphine/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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | through study completion, an average of 6 days | To examine changes in pain scores daily from the day of surgery to the hospital discharge day. |
| Postoperative Opioid Consumption | through study completion, an average of 6 days | To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group. |
| Length of Hospital Stay | through study completion, an average of 6 days | To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group. |
Countries
United States
Outcome results
None listed