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

Mass General Brigham

Status and phase: Withdrawn; Phase 4

Conditions: Post-operative Pain

Treatments: Drug: Buprenorphine/Naloxone

Study type: Interventional

Funder types: Other

Identifiers

NCT04771689

2021P000553

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Buprenorphine/Naloxone

Active Comparator group

Description:

Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed.

Treatment:

Drug: Buprenorphine/Naloxone

Standard Medication Regiment

No Intervention group

Description:

Subjects will take conventional intravenous or oral opioid management.