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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771689
Recruitment Status : Not yet recruiting
First Posted : February 25, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Yi Zhang, MD, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Post-operative Pain Drug: Buprenorphine/Naloxone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
Estimated Study Start Date : July 1, 2022
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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.
Other Name: Suboxone
No Intervention: Standard Medication Regiment
Subjects will take conventional intravenous or oral opioid management.


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative Pain Scores [ Time Frame: 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.

  2. Postoperative Opioid Consumption [ Time Frame: 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.

  3. Length of Hospital Stay [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771689


Contacts
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Contact: Karina de Sousa, BS 617-724-6102 kdesousa1@mgh.harvard.edu
Contact: Grace Mogren, BS 617-724-6102 gmogren@mgh.harvard.edu

Locations
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United States, Massachusetts
Karina de Sousa
Boston, Massachusetts, United States, 02114
Contact: Karina de Sousa, BS    617-724-6102    kdesousa1@mgh.harvard.edu   
Contact: Grace Mogren, BS    617-724-6102    gmogren@mgh.harvard.edu   
Principal Investigator: Yi Zhang, MD, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Yi Zhang, MD, PhD Massachusetts General Hospital
More Information
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Additional Information:

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Responsible Party: Yi Zhang, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04771689    
Other Study ID Numbers: 2021P000553
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data may be shared with other researchers in the future.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yi Zhang, MD, Massachusetts General Hospital:
pain
pain management
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
 Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists