ACL SurgeryPhase 4NCT07158476
Efficacy of Methylprednisolone for Pain Control After ACL Repair
A Phase 4 study testing Meloxicam 15 mg, Medrol 4 MG Oral Tablet Includes Medrol Dosepak and Gabapentin 300 mg in people with ACL Surgery and Pain Management, run by St. Louis University at 1 site in United States.
Trial summary
Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to… Read more about this study
- Who is it for?
- Ages 13 to 50 years
- Conditions the study is for
- ACL Surgery, Pain Management
- What is being tested?
- Meloxicam 15 mg, Medrol 4 MG Oral Tablet Includes Medrol Dosepak and Gabapentin 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2025to Sep 2031
- Phase
- Phase 4
- 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 13 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient undergoing ACL repair or ACL reconstruction with tendon autograft
- Age 13-50 years old
- Able to provide informed consent or parent/legal guardian is able for minors
Who cannot join
- Concurrent and significant injury to other bones or organs (Injury Severity Score of 4 or greater)
- Revision ACL reconstruction
- Concomitant additional ligament reconstruction or high tibial osteotomy
- A history of alcohol abuse, substance abuse or chronic opioid use (filled opioid medication ×2 within 6 months of the surgery)
- A history of renal failure (<60 mL/min/1.73 m2), liver dysfunction (child class, >B), severe heart disease (NYHA Class 4), diabetes, neurological or psychiatric diseases that may affect pain perception, and pre-existing immune suppression.
- A history or active peptic ulcer disease, gastrointestinal bleeding, or current use of anticoagulation.
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- Patients currently taking oral or injectable glucocorticoids and those who have taken either within 1 month of the procedure.
- Patients who are currently pregnant.
- Patients who are unable to undergo the multimodal pain standardized protocol including those with comorbidities or medical allergies precluding the use of corticosteroids, gabapentin, hydrocodone, acetaminophen, ketorolac, and/or meloxicam.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Saint Louis University
St Louis, Missouri, 63110
About this study
Official title: Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.
Read the detailed description
The study is to include consecutive patients who undergo ACL repair by fellowship trained surgeons at a single institution with minimum 12 week follow up. All patients between the ages of 13-50 who are willing and able to provide informed consent will be included. Patients will be assessed preoperatively and then at 2 weeks, 6 weeks,12 weeks, and 1 year clinic visits, which is standard of care. The patient will fill out 2 questions on the MyCap app the day of surgery and for 14 days following surgery for pain scores and 15 days for amount of opioid pills consumed the day prior. Patient demographic, comorbidity, and surgical data will be collected from the medical record, including age, sex, BMI, smoking status, and diabetic status.
Patients will be randomized to the treatment or control group. The treatment group will receive the following pain regimen after surgery: Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin. The control group will be prescribed: Ketoralac, Hydrocodone/Acetaminophen, and Gabapentin. Pain reporting and opioid consumption will be assessed via the MyCap app for two weeks following surgery.
Patients will be followed at standard of care clinic appointments for 1 year. PROMs data will be collected at that time, in addition to any complications.
- Conditions
- ACL Surgery, Pain Management
- Being tested
- Meloxicam 15 mg, Medrol 4 MG Oral Tablet Includes Medrol Dosepak, Gabapentin 300 mg, Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Ketorolac 10 Mg Oral Tablet
- Keywords
- pain, opioids, orthopedic surgery
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meloxicam 15 mgDrug
PO once/day for 1 week
Medrol 4 MG Oral Tablet Includes Medrol DosepakDrug
PO 6 day taper
Gabapentin 300 mgDrug
PO every 8 hours for 1 week
Hydrocodone 5Mg/Acetaminophen 325Mg TabDrug
PO 1-2 tabs every 4 hours as needed (total of 28 pills)
Ketorolac 10 Mg Oral TabletDrug
PO every 6 hours for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Medrol group | Active comparator | Patients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. Receives: Drug: Meloxicam 15 mg; Drug: Medrol 4 MG Oral Tablet Includes Medrol Dosepak; Drug: Gabapentin 300 mg; Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab |
| No Medrol group | Active comparator | Patients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. Receives: Drug: Gabapentin 300 mg; Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab; Drug: Ketorolac 10 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) pain scores
Zero is equivalent to no pain and 10 indicates the worst possible pain
Measured: Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks
Secondary outcomes (1)
Opioid consumption after surgery
Calculated using Morphine milligram equivalents (MME)
Measured: 0-14 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start21 Oct 2025
- Primary completionSep 2030 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL SurgeryStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Kaar, MD, St. Louis University
- Investigators
- Scott Kaar, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158476
- Sponsor's protocol ID
- 34336
- Status last verified
- Oct 2025
- First submitted
- 28 Aug 2025
- Last updated
- 24 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Methylprednisolone for Pain Control After ACL Repair: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07158476
- Acronym / sponsor ID
- 34336
- Conditions
- ACL Surgery, Pain Management
- Keywords
- pain, opioids, orthopedic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 5 Sep 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.
Opioids are commonly used after orthopedic surgery for pain control but have been shown to increase complications, surgeries, readmissions, and risk for opioid use disorder. The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this results in decreased postoperative pain and opioid use without increasing complications.
Detailed description
The study is to include consecutive patients who undergo ACL repair by fellowship trained surgeons at a single institution with minimum 12 week follow up. All patients between the ages of 13-50 who are willing and able to provide informed consent will be included. Patients will be assessed preoperatively and then at 2 weeks, 6 weeks,12 weeks, and 1 year clinic visits, which is standard of care. The patient will fill out 2 questions on the MyCap app the day of surgery and for 14 days following surgery for pain scores and 15 days for amount of opioid pills consumed the day prior. Patient demographic, comorbidity, and surgical data will be collected from the medical record, including age, sex, BMI, smoking status, and diabetic status.
Patients will be randomized to the treatment or control group. The treatment group will receive the following pain regimen after surgery: Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin. The control group will be prescribed: Ketoralac, Hydrocodone/Acetaminophen, and Gabapentin. Pain reporting and opioid consumption will be assessed via the MyCap app for two weeks following surgery.
Patients will be followed at standard of care clinic appointments for 1 year. PROMs data will be collected at that time, in addition to any complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medrol group | Active comparator | Drug: Meloxicam 15 mg, Drug: Medrol 4 MG Oral Tablet Includes Medrol Dosepak, Drug: Gabapentin 300 mg, Drug: Hydrocodone 5Mg/Acetaminophen 325Mg TabPatients will receive Medrol dose pack, Meloxicam, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. |
| No Medrol group | Active comparator | Drug: Gabapentin 300 mg, Drug: Hydrocodone 5Mg/Acetaminophen 325Mg Tab, Drug: Ketorolac 10 Mg Oral TabletPatients will receive Ketorolac, Hydrocodone/Acetaminophen, and Gabapentin as pain regimen upon discharge from surgery. |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patient undergoing ACL repair or ACL reconstruction with tendon autograft
- Age 13-50 years old
- Able to provide informed consent or parent/legal guardian is able for minors
Key exclusion criteria (9 listed)
- Concurrent and significant injury to other bones or organs (Injury Severity Score of 4 or greater)
- Revision ACL reconstruction
- Concomitant additional ligament reconstruction or high tibial osteotomy
- A history of alcohol abuse, substance abuse or chronic opioid use (filled opioid medication ×2 within 6 months of the surgery)
- A history of renal failure (<60 mL/min/1.73 m2), liver dysfunction (child class, >B), severe heart disease (NYHA Class 4), diabetes, neurological or psychiatric diseases that may affect pain perception, and pre-existing immune suppression.
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 |
|---|---|---|
| Meloxicam 15 mgPO once/day for 1 week | Drug | Medrol group |
| Medrol 4 MG Oral Tablet Includes Medrol DosepakPO 6 day taper | Drug | Medrol group |
| Gabapentin 300 mgPO every 8 hours for 1 week | Drug | Medrol group, No Medrol group |
| Hydrocodone 5Mg/Acetaminophen 325Mg TabPO 1-2 tabs every 4 hours as needed (total of 28 pills) | Drug | Medrol group, No Medrol group |
| Ketorolac 10 Mg Oral TabletPO every 6 hours for 5 days | Drug | No Medrol group |
Primary outcome
Numerical Rating Scale (NRS) pain scores
Time frame: Post-op days 0-14, 2 weeks, 6 weeks, and 12 weeks
Zero is equivalent to no pain and 10 indicates the worst possible pain
1 secondary outcome
Opioid consumption after surgery
Time frame: 0-14 days postoperative
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 24 Oct 2025.
- 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.
Scott Kaar, MD principal investigator
St. Louis University
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 Meloxicam 15 mg, Medrol 4 MG Oral Tablet Includes Medrol Dosepak and Gabapentin 300 mg in people with ACL Surgery and Pain Management, run by St. Louis University 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 3 inclusion and 9 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 24 Oct 2025. 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?
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 Scott Kaar (314-617-3405, scott.kaar@ssmhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) pain scores (time frame: Post-op days 0-14, 2 weeks, 6 weeks, and 12 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 24 Oct 2025.