Orthopaedic Related Pain (Musculoskeletal Pain)NCT07265557
Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients
A study testing Discharge pain medication prescription in people with Orthopaedic Related Pain (Musculoskeletal Pain) and Opioid, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthopaedic Related Pain (Musculoskeletal Pain), Opioid, Pain
- What is being tested?
- Discharge pain medication prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients 18 years of age or older
- Underwent a major operative orthopaedic procedure
Who cannot join
- Contraindication for NSAIDs.
- Preoperative chronic opioid use (preoperative use of >14 days and average of >30 Morphine Milligram Equivalents per day).
- Active treatment for opioid use disorder.
- Previous or current illicit drug use.
- Major surgery for pathologic (cancer-related) condition.
- Hand surgery.
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- Concurrent operative treatment by another specialty team.
- Discharged to an extended medical care facility.
- Incarceration.
- Women who are pregnant or planning to become pregnant in the next 6 weeks.
- Expected injury survival of less than 6 weeks.
- Terminal illness with expected survival of less than 6 weeks.
- Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.
- Currently enrolled in a trial that does not permit co-enrollment.
- Prior enrollment in the trial.
- Unable to obtain informed consent.
- Non-English speaking
- Eligible patient was not approached prior to hospital discharge (missed participant).
- Did not provide informed consent (declined participation).
- Other reason to exclude the patient, as approved by the Principal Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sheila Sprague, PhD contact
United States1 site, 1 recruiting
- Recruiting
Mass
Boston, Massachusetts, 02114
Arun Aneja, MD, PhD, 617-726-6546, aaneja@mgh.harvard.edu
About this study
Official title: A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study
This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.
Read the detailed description
This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.
- Being tested
- Discharge pain medication prescription
- Keywords
- Opioid, Pilot study, Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Discharge pain medication prescriptionOther
The patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Discharge pain medication prescription without opioids | Experimental | The treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. Receives: Other: Discharge pain medication prescription |
| Usual care discharge prescription (with opioids) | Active comparator | The control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician. Receives: Other: Discharge pain medication prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of patient enrollment and treatment allocation
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including:
- Participant enrollment
- Feasibility of treatment allocation
- Data collection methods (Proportion of participants with missing data)
- Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)
Measured: From enrollment to the end of the follow-up phase at 6 weeks
Secondary outcomes (2)
Opioid Use
Opioid usage assessed at 2 weeks and 6 weeks post-randomization
Measured: From enrollment to the end of the follow-up at 6 weeks
Pain Interference
Pain interference will be assessed using the Brief Pain Inventory at 2 weeks and 6 weeks from randomization.
Measured: From enrollment to the end of the follow-up at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start6 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopaedic Related Pain (Musculoskeletal Pain)Studies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Arun Aneja, MD, PhD, Massachusetts General Hospital
- Investigators
- Arun Aneja, MD PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07265557
- Sponsor's protocol ID
- 2025P002285
- Status last verified
- Jan 2026
- First submitted
- 14 Oct 2025
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Comparing Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT07265557
- Acronym / sponsor ID
- 2025P002285
- Keywords
- Opioid, Pilot study, Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2025 (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.
This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.
Detailed description
This is a single-center pilot RCT of at least 100 participants (20 participants from each subspecialty including trauma, arthroplasty, foot and ankle, spine, and sports) who undergo major orthopaedic surgery. Eligible and consenting patients will be randomized to either a discharge pain medication prescription without opioids or a usual care discharge pain medication (with opioids). The overarching objective of the pilot study is to inform the design and feasibility of the definitive RCT. For this pilot trial the investigators will measure feasibility against traffic light criteria based on enrollment metrics, treatment allocation adherence, and on data collection. Furthermore, this pilot RCT will compare the effectiveness of discharge pain medication without opioids to usual care discharge pain medication (with opioids) on opioid use and pain interference for patients who have undergone major orthopaedic surgery.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Discharge pain medication prescription without opioids | Experimental | Other: Discharge pain medication prescriptionThe treatment arm will receive standard non-opioid analgesia, with the specific medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. |
| Usual care discharge prescription (with opioids) | Active comparator | Other: Discharge pain medication prescriptionThe control arm will receive the standard pain medication prescription, including opioids. The specific dosage and medication is determined by the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Underwent a major operative orthopaedic procedure
Key exclusion criteria (20 listed)
- Contraindication for NSAIDs.
- Preoperative chronic opioid use (preoperative use of >14 days and average of >30 Morphine Milligram Equivalents per day).
- Active treatment for opioid use disorder.
- Previous or current illicit drug use.
- Major surgery for pathologic (cancer-related) condition.
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 |
|---|---|---|
| Discharge pain medication prescriptionThe patients in this pilot RCT will either receive a discharge prescription with or without opioids. The specific non-opioid medication (e.g., ibuprofen, paracetamol, ketorolac) determined by the treating physician. The dosage of the prescription including opioids is also determined by the treating physician. | Other | Discharge pain medication prescription without opioids, Usual care discharge prescription (with opioids) |
Primary outcome
Feasibility of patient enrollment and treatment allocation
Time frame: From enrollment to the end of the follow-up phase at 6 weeks
Participant enrollment will be assessed by monitoring screening and enrollment metrics, including: * Participant enrollment * Feasibility of treatment allocation * Data collection methods (Proportion of participants with missing data) * Compliance with the protocol (Proportion of randomization errors, proportion of patients who complete each questionnaire at each of the follow-up, proportion of patients who withdraw from the trial, proportion of participants who are lost to follow-up)
2 secondary outcomes
Opioid Use
Time frame: From enrollment to the end of the follow-up at 6 weeks
Pain Interference
Time frame: From enrollment to the end of the follow-up at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Sheila Sprague, PhD contact
Arun Aneja, 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 study testing Discharge pain medication prescription in people with Orthopaedic Related Pain (Musculoskeletal Pain) and Opioid, 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 2 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 25 Jun 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arun Aneja, MD, PhD (617-726-6546, aaneja@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of patient enrollment and treatment allocation (time frame: From enrollment to the end of the follow-up phase at 6 weeks). 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 25 Jun 2026.