Post-operative PainPhase 4NCT04771689
Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
A Phase 4 study testing Buprenorphine/Naloxone in people with Post-operative Pain, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Buprenorphine/Naloxone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Undergoing orthopedic or general surgery
- 18 years of age or older
- Willing and able to adhere to the study protocol and follow-up schedule
- Able to provide written informed consent to participate in the clinical trial
- If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study
Who cannot join
- Buprenorphine or buprenorphine/naloxone use in the last two weeks
- Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
- Patients receiving postoperative ketamine or lidocaine boluses or infusions
- Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
- Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
- Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
Show all 12Show fewer
- Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
- Positive pregnancy test for women of childbearing potential
- Known allergy or sensitivity to bup/nx
- 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
- Current participation in additional pharmacologic research study
- Active suicidal ideation as determined by PI or study clinician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
- Conditions
- Post-operative Pain
- Being tested
- Buprenorphine/Naloxone
- Keywords
- pain, pain management
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/NaloxoneDrug
Also called Suboxone
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.
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine/Naloxone | Active comparator | Subjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed. Receives: Drug: Buprenorphine/Naloxone |
| Standard Medication Regiment | No intervention | Subjects will take conventional intravenous or oral opioid management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Scores
To examine changes in pain scores daily from the day of surgery to the hospital discharge day.
Measured: through study completion, an average of 6 days
Postoperative Opioid Consumption
To compare opioid consumption after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
Measured: through study completion, an average of 6 days
Length of Hospital Stay
To compare the length of hospital stay after surgery between the buprenorphine/naloxone group and the standard medication regiment group.
Measured: through study completion, an average of 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Zhang, MD, Massachusetts General Hospital
- Investigators
- Yi Zhang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771689
- Sponsor's protocol ID
- 2021P000553
- Status last verified
- Jan 2026
- First submitted
- 23 Feb 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data may be shared with other researchers in the future.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
- ClinicalTrials.gov ID
- NCT04771689
- Acronym / sponsor ID
- 2021P000553
- Conditions
- Post-operative Pain
- Keywords
- pain, pain management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine/Naloxone | Active comparator | Drug: Buprenorphine/NaloxoneSubjects will take a maximum dose of 4 mg buprenorphine and 1 mg naloxone with concurrent administration of other intravenous or oral opioids needed. |
| Standard Medication Regiment | No intervention | –Subjects will take conventional intravenous or oral opioid management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Undergoing orthopedic or general surgery
- 18 years of age or older
- Willing and able to adhere to the study protocol and follow-up schedule
- Able to provide written informed consent to participate in the clinical trial
Key exclusion criteria (12 listed)
- Buprenorphine or buprenorphine/naloxone use in the last two weeks
- Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
- Patients receiving postoperative ketamine or lidocaine boluses or infusions
- Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
- Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Buprenorphine/NaloxoneAlso: SuboxoneSubjects 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. | Drug | Buprenorphine/Naloxone |
Primary outcome
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Massachusetts General Hospital Center for Translational Pain ResearchLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Deidentified data may be shared with other researchers in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Zhang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine/Naloxone in people with Post-operative Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Scores (time frame: through study completion, an average of 6 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.