KetorolacPhase 3NCT04872283
Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion
A Phase 3 study testing great toe (1st metatarsophalangeal joint) fusion, IV Ketorolac and Ketorolac Pill in people with Ketorolac and Joint Fusion, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketorolac, Joint Fusion
- What is being tested?
- great toe (1st metatarsophalangeal joint) fusion, IV Ketorolac and Ketorolac Pill
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 31 Dec 2021
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute
Who cannot join
- Patients undergoing revision 1st MTPJ fusion;
- Patients with any allergies to any study medication;
- Patients with documented chronic narcotic use;
- Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
- Patients who are pregnant;
- Patients undergoing inpatient procedure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion
In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing.
When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications.
The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.
- Conditions
- Ketorolac, Joint Fusion
- Being tested
- great toe (1st metatarsophalangeal joint) fusion, IV Ketorolac, Ketorolac Pill, 5/325mg Oxycodone-Acetaminophen, Aspirin 81Mg Ec Tab
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
great toe (1st metatarsophalangeal joint) fusionProcedure or surgery
Great Toe joint fusion surgery
IV KetorolacDrug
Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery
Ketorolac PillDrug
Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain
5/325mg Oxycodone-AcetaminophenDrug
Participants will receive 30 tablets of 5/325mg oxycodone-acetaminophen with instructions to take 1 or 2 tablets by mouth every 4 to 6 hours as needed for pain
Aspirin 81Mg Ec TabDrug
Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac administration | Active comparator | Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain Receives: Procedure: great toe (1st metatarsophalangeal joint) fusion; Drug: IV Ketorolac; Drug: Ketorolac Pill; Drug: 5/325mg Oxycodone-Acetaminophen; Drug: Aspirin 81Mg Ec Tab |
| No Ketorolac administration | Active comparator | Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain Receives: Procedure: great toe (1st metatarsophalangeal joint) fusion; Drug: 5/325mg Oxycodone-Acetaminophen; Drug: Aspirin 81Mg Ec Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain
Measured: 7 days
Satisfaction with pain management
This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied)
Measured: 7 days
Participant Perception of Pain
This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start23 May 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetorolacStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872283
- Sponsor's protocol ID
- JONE19D.372
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion
- ClinicalTrials.gov ID
- NCT04872283
- Acronym / sponsor ID
- JONE19D.372
- Conditions
- Ketorolac, Joint Fusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 4 May 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.
In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing.
When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications.
The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketorolac administration | Active comparator | Procedure: great toe (1st metatarsophalangeal joint) fusion, Drug: IV Ketorolac, Drug: Ketorolac Pill, Drug: 5/325mg Oxycodone-Acetaminophen, Drug: Aspirin 81Mg Ec TabParticipants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain |
| No Ketorolac administration | Active comparator | Procedure: great toe (1st metatarsophalangeal joint) fusion, Drug: 5/325mg Oxycodone-Acetaminophen, Drug: Aspirin 81Mg Ec TabParticipants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute
Key exclusion criteria (6 listed)
- Patients undergoing revision 1st MTPJ fusion;
- Patients with any allergies to any study medication;
- Patients with documented chronic narcotic use;
- Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
- Patients who are pregnant;
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 |
|---|---|---|
| great toe (1st metatarsophalangeal joint) fusionGreat Toe joint fusion surgery | Procedure or surgery | Ketorolac administration, No Ketorolac administration |
| IV KetorolacParticipants will receive 30mg of intravenous (IV) ketorolac will be given during surgery | Drug | Ketorolac administration |
| Ketorolac PillParticipants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain | Drug | Ketorolac administration |
| 5/325mg Oxycodone-AcetaminophenParticipants will receive 30 tablets of 5/325mg oxycodone-acetaminophen with instructions to take 1 or 2 tablets by mouth every 4 to 6 hours as needed for pain | Drug | Ketorolac administration, No Ketorolac administration |
| Aspirin 81Mg Ec TabParticipants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT) | Drug | Ketorolac administration, No Ketorolac administration |
Primary outcome
Postoperative Pain
Time frame: 7 days
Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain
Satisfaction with pain management
Time frame: 7 days
This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied)
Participant Perception of Pain
Time frame: 7 days
This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 great toe (1st metatarsophalangeal joint) fusion, IV Ketorolac and Ketorolac Pill in people with Ketorolac and Joint Fusion, run by Rothman Institute Orthopaedics 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 May 2021. 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?
Results are not available in the source record.
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 (time frame: 7 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 4 May 2021.