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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04771689
• Other study ID #: 2021P000553
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 1, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: Karina de Sousa, BS
• Phone: 617-724-6102
• Email: kdesousa1[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Karina de Sousa	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Massachusetts General Hospital Center for Translational Pain Research