ACL - Anterior Cruciate Ligament RupturePhase 2NCT06973785
Non-Narcotic Pain Control After ACL Reconstruction
A Phase 2 study testing dispense of study drug and Ketorolac in people with ACL - Anterior Cruciate Ligament Rupture and ACL Injuries, run by The Cleveland Clinic at 3 sites in United States.
Trial summary
This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero… Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- ACL - Anterior Cruciate Ligament Rupture, ACL Injuries
- What is being tested?
- dispense of study drug and Ketorolac
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Jul 2025to 15 Jun 2027
- Phase
- Phase 2
- 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15-55 years
- Primary Autograft ACL surgery
- Ability to take oral medication and willingness to patriciate in a virtual 1 week follow-up pill count visit
Who cannot join
- 1. Any extensor mechanism dislocation or disruption 2. Multi-ligament injury that requires repair 3. Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control 4. Psychiatric illness that impedes evaluation of pain and/or narcotics use 5. History of Chronic Kidney Disease 6. History of inflammatory arthritis, diabetes, or autoimmune disease 7. History of GI bleed or documented GI ulcer (diagnosed by endoscopy) 8. Allograft or revision of ACLR 9. Contraindications to ketorolac or opioids
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cleveland Clinic Coral Springs
Coral Springs, Florida, 33067
Cleveland clinic sports medicine
Garfield, Ohio, 44125
Cleveland Clinic
Strongsville, Ohio, 44136
About this study
This is a double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.
Read the detailed description
This is a multi-center, 2 arm, randomized 1:1 controlled trial, with a blinded patient and outcome assessment study. Narcotics are currently the standard of care as part multimodal pain control in major joint surgery including ACLR. Twelve (12) ketorolac (10mg) and twelve (12) oxycodone (5mg) tablets will be shrouded in identical capsules for the pain packet designed for blinding. The capsules will be dispensed in sealed single-pill release blister packets. The enrolled patients will be randomized by the surgeon. The surgeon, clinical team, and patient will be blinded as to treatment (double-blind study). The rescue medication will be specific to each treatment group, encapsulated for blinding, and in a packet labeled RESCUE medication. For the experimental group (ketorolac) they will have 9 oxycodone as rescue medication. For the control group (oxycodone) they will have 9 diclofenac as rescue medication. Both groups will also be given acetaminophen for the first 72 hours. All medications in our multimodal approach will be provided postoperatively after ACL reconstruction to both groups. The primary endpoint will be the percentage reduction in narcotics pills per patient in each group in first 72 hours postoperatively verified from sealed packages.
- Being tested
- dispense of study drug, Ketorolac
- Keywords
- acl, Narcotic use
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dispense of study drugDrug
Also called oxycontin
- Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen
KetorolacDrug
Also called Toradol
Patients will be randomized to either Ketorolac or Oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone- Narcotic | Active comparator | Arm 1 Receives: Drug: Ketorolac |
| Ketorolac | Placebo comparator | Arm 2 Receives: Drug: dispense of study drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
How many narcotic pills were consumed
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start15 Jul 2025
- Primary completion12 Jun 2026
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL - Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kurt Spindler, MD, The Cleveland Clinic
- Investigators
- Kurt P Spindler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973785
- Sponsor's protocol ID
- 24-1207
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD will be used in the results publications
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Narcotic Pain Control After ACL Reconstruction
- ClinicalTrials.gov ID
- NCT06973785
- Acronym / sponsor ID
- 24-1207
- Keywords
- acl, Narcotic use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 15 May 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 double-blind randomized controlled trial of standard of care therapy, either oral ketorolac (experimental group) or oral oxycodone (control group) to demonstrate efficacy in reducing the percentage of narcotic doses taken and documenting the number of patients with no exposure to any narcotics (take zero oxycodone) after undergoing primary knee ACL reconstruction outpatient surgery.
Detailed description
This is a multi-center, 2 arm, randomized 1:1 controlled trial, with a blinded patient and outcome assessment study. Narcotics are currently the standard of care as part multimodal pain control in major joint surgery including ACLR. Twelve (12) ketorolac (10mg) and twelve (12) oxycodone (5mg) tablets will be shrouded in identical capsules for the pain packet designed for blinding. The capsules will be dispensed in sealed single-pill release blister packets. The enrolled patients will be randomized by the surgeon. The surgeon, clinical team, and patient will be blinded as to treatment (double-blind study). The rescue medication will be specific to each treatment group, encapsulated for blinding, and in a packet labeled RESCUE medication. For the experimental group (ketorolac) they will have 9 oxycodone as rescue medication. For the control group (oxycodone) they will have 9 diclofenac as rescue medication. Both groups will also be given acetaminophen for the first 72 hours. All medications in our multimodal approach will be provided postoperatively after ACL reconstruction to both groups. The primary endpoint will be the percentage reduction in narcotics pills per patient in each group in first 72 hours postoperatively verified from sealed packages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone- Narcotic | Active comparator | Drug: KetorolacArm 1 |
| Ketorolac | Placebo comparator | Drug: dispense of study drugArm 2 |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 15-55 years
- Primary Autograft ACL surgery
- Ability to take oral medication and willingness to patriciate in a virtual 1 week follow-up pill count visit
Key exclusion criteria (2 listed)
- 1. Any extensor mechanism dislocation or disruption 2. Multi-ligament injury that requires repair 3. Treatment with another investigational drug or other intervention concurrently or previously that would interfere with postoperative pain control 4. Psychiatric illness that impedes evaluation of pain and/or narcotics use 5. History of Chronic Kidney Disease 6. History of inflammatory arthritis, diabetes, or autoimmune disease 7. History of GI bleed or documented GI ulcer (diagnosed by endoscopy) 8. Allograft or revision of ACLR 9. Contraindications to ketorolac or opioids
- -
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 |
|---|---|---|
| dispense of study drugAlso: oxycontin• Cohort Group 1 (Experimental): ketorolac 10mg with rescue medication oxycodone 5mg All patients will be given acetaminophen | Drug | Ketorolac |
| KetorolacAlso: ToradolPatients will be randomized to either Ketorolac or Oxycodone | Drug | Oxycodone- Narcotic |
Primary outcome
Primary outcome
Time frame: 30 days
How many narcotic pills were consumed
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 Aug 2026.
- Individual participant dataSharing planned: Yes. Only IPD will be used in the results publications
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Preventing Injured Knees From osteoArthritis: Severity Outcomes
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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.
Kurt P Spindler, MD principal investigator
The Cleveland Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dispense of study drug and Ketorolac in people with ACL - Anterior Cruciate Ligament Rupture and ACL Injuries, run by The Cleveland Clinic at 3 sites 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 5 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
Primary outcome (time frame: 30 days). 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 Aug 2026.