Meniscus Tear, TibialPhase 3NCT04246541
Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
A Phase 3 study testing Ketorolac and Oxycodone-Acetaminophen in people with Meniscus Tear, Tibial and Pain, Postoperative, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications
- What is being tested?
- Ketorolac and Oxycodone-Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2019to 12 Sep 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18 and 89 years of age
- Patients undergoing primary arthroscopic meniscus surgery
Who cannot join
- Patients age less than 18 or greater than 89 years
- Illiterate or non-English speaking patients
- Patients with contraindications to ketorolac
- History of drug or alcohol abuse
- Chronic use of analgesic or psychotropic drugs
Trial locations and contacts
1 site in 1 country.
About this study
The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.
- Conditions
- Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction, Opioid Use
- Being tested
- Ketorolac, Oxycodone-Acetaminophen
- Keywords
- ketorolac, meniscus tear, analgesics, pain
- Medical subject headings
- Tibial Meniscus Injuries, Pain, Postoperative, Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
Oxycodone-AcetaminophenDrug
Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Patients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery Receives: Drug: Oxycodone-Acetaminophen |
| Ketorolac | Experimental | Patients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels Recorded With a Visual Analogue Scale
Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.
Measured: 2 weeks postoperatively
Narcotic Medication Consumed
Number of oxycodone- acetaminophen tablets consumed
Measured: up to 5 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start23 Apr 2019
- Primary completion12 Sep 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniscus Tear, TibialStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Karns, MD., University Hospitals Cleveland Medical Center
- Investigators
- Michael Karns, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246541
- Sponsor's protocol ID
- STUDY20181100
- Status last verified
- Mar 2022
- First submitted
- 24 Jan 2020
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketorolac as an Adjuvant Agent for Postoperative Pain Control Following Arthroscopic Meniscus Surgery
- ClinicalTrials.gov ID
- NCT04246541
- Acronym / sponsor ID
- STUDY20181100
- Conditions
- Meniscus Tear, Tibial, Pain, Postoperative, Postoperative Complications, Ketorolac Adverse Reaction, Opioid Use
- Keywords
- ketorolac, meniscus tear, analgesics, pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 23 Apr 2019 (actual)
- Primary completion
- 12 Sep 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 29 Jan 2020 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The utilization of arthroscopic surgery to treat meniscus injuries has continued to increase in recent years, partly due to a younger, more active population, and improved technology and technique. However, pain management in the post-operative period is critical to the ability to perform this procedure as an outpatient surgery. Traditionally, oral narcotic agents have been the preferred analgesic postoperatively in orthopaedic surgery. However, these agents are associated with several side effects, including nausea/vomiting, constipation, and somnolence. In addition, opioid agents have a significant potential for abuse in comparison to non-narcotic analgesics. In light of the rising opioid epidemic and nationwide initiatives to limit narcotic usage, surgeons must explore alternate pain modalities in the acute postoperative period. Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-inflammatory properties.1 Multiple prior studies have examined the beneficial effect of oral and intravenous (IV) ketorolac as an analgesic in the postoperative period,1-3 including arthroscopic meniscus surgery. However, the beneficial effects of this agent following arthroscopic meniscus surgery have not been extensively described.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Drug: Oxycodone-AcetaminophenPatients will receive standard of care Percocet for post-operative pain control following meniscus debridement surgery |
| Ketorolac | Experimental | Drug: KetorolacPatients will receive IV ketorolac during surgery. They will then receive 3 days of oral ketorolac every 6 hours for pain control following surgery. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients between 18 and 89 years of age
- Patients undergoing primary arthroscopic meniscus surgery
Key exclusion criteria (5 listed)
- Patients age less than 18 or greater than 89 years
- Illiterate or non-English speaking patients
- Patients with contraindications to ketorolac
- History of drug or alcohol abuse
- Chronic use of analgesic or psychotropic drugs
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 |
|---|---|---|
| KetorolacPatients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac. | Drug | Ketorolac |
| Oxycodone-AcetaminophenPatients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery. | Drug | Control |
Primary outcome
Pain Levels Recorded With a Visual Analogue Scale
Time frame: 2 weeks postoperatively
Patients will record pain levels post-operatively using a visual analogue scale (VAS) ranging from 0 as the minimum value to 100 as the maximum value. A smaller VAS value will be considered a lower pain level.
Narcotic Medication Consumed
Time frame: up to 5 days postoperatively
Number of oxycodone- acetaminophen tablets consumed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meniscus Tear, Tibial
Recruiting
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Meniscus Tear, Tibial
Recruiting
Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
Knee Osteoarthristis, Meniscus Injury
RecruitingObservational study
Clinical Outcomes of Arthroscopic Surgeries for Shoulder and Knee Sports Injuries
Athletic Injuries (C26.857.500.124), Rotator Cuff Injuries
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.
Michael Karns, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac and Oxycodone-Acetaminophen in people with Meniscus Tear, Tibial and Pain, Postoperative, run by University Hospitals Cleveland Medical Center 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 5 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: finished, as of the sponsor's last update on 3 Mar 2022. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Levels Recorded With a Visual Analogue Scale (time frame: 2 weeks postoperatively). The study lists 2 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 3 Mar 2022.