ArthrodesisPhase 1NCT05054868
Ketorolac vs Oxycodone for Great Toe Arthrodesis
A Phase 1 study testing Oxycodone and Ketorolac in people with Arthrodesis, run by Medstar Health Research Institute at 1 site in United States.
Trial summary
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthrodesis
- What is being tested?
- Oxycodone and Ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to 31 Jul 2024
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 - 75 years.
- Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
- Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).
Who cannot join
- Chronic pain syndrome, CRPS or fibromyalgia
- Revision procedures
- Use of allograft bone at the fusion site
- Tobacco use
- Diabetes
- Narcotic abuse or IV drug abuse
Show all 12Show fewer
- Any CPT codes involving the midfoot, hindfoot, and/or ankle
- Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
- Weight < 50 kg
- Does not speak or read English
- If pregnant or planning to become pregnant or breastfeeding
- Non-independent dweller (prisoner)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Amy Loveland
Baltimore, Maryland, 21218
Amy Loveland, 301-560-2937, amy.loveland@medstar.net
Crisanto Macaraeg, 4102618218, crisanto.l.macaraeg@medstar.net
About this study
Official title: Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.
Read the detailed description
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.
- Conditions
- Arthrodesis
- Being tested
- Oxycodone, Ketorolac
- Keywords
- big toe arthrodesis, big toe, joint fusion
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
KetorolacDrug
Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control group) - Oxycodone only | Active comparator | Subjects randomized to this group will receive oxycodone for postop pain management (standard of care). Receives: Drug: Oxycodone |
| Group 2 (Treatment group) - Oxycodone and Ketorolac | Experimental | Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management. Receives: Drug: Oxycodone; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery.
Measured: From baseline to 14 days after the surgery
Quantitative pain management - measured using a study survey.
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions-
- number of pills (oxycodone and/or ketorolac) consumed
- if the pain medicine(s) needed to be refilled
- discontinuation date \& reason
- side effects, if any
- the effectiveness of the pain medicine(s)
- preference for ketorolac or oxycodone, if applicable
Measured: 14 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start14 Apr 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrodesisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054868
- Sponsor's protocol ID
- STUDY00001123
- Status last verified
- Jul 2023
- First submitted
- 23 Jul 2021
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis
- ClinicalTrials.gov ID
- NCT05054868
- Acronym / sponsor ID
- STUDY00001123
- Conditions
- Arthrodesis
- Keywords
- big toe arthrodesis, big toe, joint fusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 23 Sep 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.
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.
Detailed description
This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control group) - Oxycodone only | Active comparator | Drug: OxycodoneSubjects randomized to this group will receive oxycodone for postop pain management (standard of care). |
| Group 2 (Treatment group) - Oxycodone and Ketorolac | Experimental | Drug: Oxycodone, Drug: KetorolacSubjects randomized to this group will receive oxycodone and ketorolac for postop pain management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 75 years.
- Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac.
- Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270).
Key exclusion criteria (12 listed)
- Chronic pain syndrome, CRPS or fibromyalgia
- Revision procedures
- Use of allograft bone at the fusion site
- Tobacco use
- Diabetes
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 |
|---|---|---|
| OxycodoneSubjects randomized to the control group will receive oxycodone for postop pain management (standard of care). | Drug | Group 1 (Control group) - Oxycodone only, Group 2 (Treatment group) - Oxycodone and Ketorolac |
| KetorolacSubjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management. | Drug | Group 2 (Treatment group) - Oxycodone and Ketorolac |
Primary outcome
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.
Time frame: From baseline to 14 days after the surgery
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery.
Quantitative pain management - measured using a study survey.
Time frame: 14 days after the surgery
To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions- * number of pills (oxycodone and/or ketorolac) consumed * if the pain medicine(s) needed to be refilled * discontinuation date \& reason * side effects, if any * the effectiveness of the pain medicine(s) * preference for ketorolac or oxycodone, if applicable
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxycodone and Ketorolac in people with Arthrodesis, run by Medstar Health Research Institute 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 12 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 12 Jul 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Amy Loveland (3015602937, amy.loveland@medstar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery. (time frame: From baseline to 14 days after the surgery). 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 12 Jul 2023.