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

Phase 4

• Conditions: Post-operative Pain
• Interventions: Drug: Buprenorphine/Naloxone

• Registration Number: NCT04771689
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-02-25
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-03
• Last Update Posted: 2021-11-04
• Study Start: 2022-07-01
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Buprenorphine/Naloxone	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Karina de Sousa; 🇺🇸 Boston, Massachusetts, United States