BunionNCT01133639
Ketorolac Effects on Post-operative Pain and Bone Healing
A study testing Ketorolac in people with Bunion, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bunion
- What is being tested?
- Ketorolac
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Feb 2012
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hallux abductus with bunion deformity
- Adult patients as defined by >=18 years old and <= 65 years old
- Subject has adequate perfusion, verified by the surgeon, which is defined by palpable pedal pulses
- Subject has voluntarily signed and dated an informed consent form, approved by IRB, and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study
- Subject agrees not to take any new medications, dietary supplements, or alternative therapies during the study period (approximately 12 weeks)
- Subject is interested in participating in the study and willing to comply with the study protocol
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- Patient has pain related to a bunion deformity but pain-free metatarsalphalangeal joint (MTPJ) range of motion that is not functionally adapted
- Adequate bone density to withstand a Kalish bunionectomy procedure
- No frontal plane hallux deformity
- Minimal abnormality of the PASA
- Normal to minimally malaligned sagittal plane position of the first metatarsal
- Failure of conservative treatment
- General Pre-operative Radiographic Angle Criteria† - 10-15 degree IMA in rectus feet* - 20-25 degree TAA in adducted feet* - 15-20 degree IMA in rectus feet if wide metatarsal head width - 25-30 degree TAA in adducted feet if wide metatarsal head width IMA=intermetatarsal angle; TAA=total adductus angle *If the pre-operative IMA is <15 degree, only the IMA will be used pre-operatively. For IMA >=15, the total adductus angle will be used †These are general guidelines and the width of the metatarsal as well as the presence of positional, structural, or combined first ray deformity may also influence procedure selection.
Who cannot join
- a history of an allergic-type reaction in response to exposure to aspirin, phenylacetic acid derivatives, or other NSAIDs
- hypersensitivity to ketorolac tromethamine, or to any product component
- any known bleeding risk or bleeding disorder, suspected or confirmed
- history of or active cerebrovascular bleeding, suspected or confirmed
- concomitant aspirin or NSAID use where the patient may not be advised to discontinue the medication during the study
- concomitant pentoxifylline use
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- concomitant probenecid use
- coronary artery bypass graft (CABG) surgery within one year of the procedure
- any history of gastrointestinal bleeding/perforation, gastrointestinal ulcer, severe peptic ulcer disease, or severe inflammatory bowel disease
- hemorrhagic diathesis, suspected or confirmed
- incomplete intraoperative hemostasis
- pre-operative serum creatinine > 1.5 ml/dL or blood urea nitrogen level > 22 mg/dL
- any history of renal impairment or risk of renal failure due to volume depletion
- Patients with a known allergy, contraindication and/or intolerance for oxycodone 5mg - acetaminophen 325 mg will be excluded from the study.
- Patients with a known allergy, contraindication, and/or intolerance for the local anesthetic (bupivicaine) or any of the standardized intra-operative opioids and anti-emetics administered by the anesthesiologist
- Patients with a history of fibromyalgia or opioid abuse
- History of chronic regional pain syndrome or diagnosis of any chronic pain syndrome, patients requiring routine methadone or other opioids
- Neuropathy or radiculopathy
- Subject has alcohol or substance abuse, dementia, brain metastases, or other cognitive disorders that may interfere with pain assessment and the post-operative course outlined by the surgeon
- American Society of Anesthesiologists (ASA) Physical Status class four or higher
- women who are pregnant, planning on becoming pregnant, or breast feeding
- presence of active local or systemic infection
- subject has a myocardial infarction in the last twelve months
- Patients who are not candidates for a Kalish bunionectomy due to the preoperative deformity as well as other study exclusions are:
- Absent pedal pulses or ABI < 0.9 and > 1.2
- Concomitant midfoot and rearfoot procedures
- Moderate to high abnormal PASA angles
- Significant sagittal plane first metatarsal deformity
- Moderate to severe osteoporosis as evaluated by preoperative radiographs and/or bone mineral density tests
- Revision cases
- History of previous infections, radiation treatment, or current infection related to the surgical site
- History of previous trauma of the first metatarsal or first ray
- Subject has known immunosuppression (HIV, recent chemotherapy, organ transplant)
- Patients taking systemic steroid (patients taking less than 5 mg of prednisone, inhaled steroids for asthma or chronic obstructive pulmonary disease, topical or optical steroids will not be excluded)
- Subject has active malignancy, excluding cutaneous malignancies except melanoma Pregnancy Elective bunion surgery will not be performed if the patient is pregnant or planning on becoming pregnant during this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Does Ketorolac Delay Bone Healing and Improve Post-operative Pain?: A Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
PlaceboDrug
Placebo plus standard of care
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo plus standard of care Receives: Drug: Placebo |
| Ketorolac | Experimental | 30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care Receives: Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Operative Pain
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Measured: Post-Operative Day 2
Osseous Healing
Radiographic assessment by a blinded board certified radiologist
Measured: 3 months
Secondary outcomes (3)
Post-operative Activity Recovery
Functional Recovery Index
Measured: up to 3 months
Adverse Events
Comparison of adverse events between the two study arms
Measured: 1 week
Quantity of Narcotic Medication
Comparison of quantity of narcotic medication utilized within the two study arms
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Why it stopped: PI no longer with the institution, funding issues, poor accrual
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 BunionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Foot and Ankle Surgeons
- Responsible party
- Principal investigator, Emily Cook, Beth Israel Deaconess Medical Center
- Investigators
- Emily A Cook, DPM, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133639
- Sponsor's protocol ID
- 2010P000047
- Status last verified
- Aug 2019
- First submitted
- 27 May 2010
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ketorolac Delay Bone Healing and Improve Post-operative Pain?: A Prospective Double-Blind Placebo-Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01133639
- Acronym / sponsor ID
- 2010P000047
- Conditions
- Bunion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI no longer with the institution, funding issues, poor accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American College of Foot and Ankle Surgeons
- Study start
- May 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 31 May 2010 (estimated)
- Results
- Posted 17 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo plus standard of care |
| Ketorolac | Experimental | Drug: Ketorolac30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hallux abductus with bunion deformity
- Adult patients as defined by >=18 years old and <= 65 years old
- Subject has adequate perfusion, verified by the surgeon, which is defined by palpable pedal pulses
- Subject has voluntarily signed and dated an informed consent form, approved by IRB, and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study
- Subject agrees not to take any new medications, dietary supplements, or alternative therapies during the study period (approximately 12 weeks)
Key exclusion criteria (35 listed)
- a history of an allergic-type reaction in response to exposure to aspirin, phenylacetic acid derivatives, or other NSAIDs
- hypersensitivity to ketorolac tromethamine, or to any product component
- any known bleeding risk or bleeding disorder, suspected or confirmed
- history of or active cerebrovascular bleeding, suspected or confirmed
- concomitant aspirin or NSAID use where the patient may not be advised to discontinue the medication during the study
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 |
|---|---|---|
| Ketorolac30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care | Drug | Ketorolac |
| PlaceboPlacebo plus standard of care | Drug | Placebo |
Primary outcome
Post-Operative Pain
Time frame: Post-Operative Day 2
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Osseous Healing
Time frame: 3 months
Radiographic assessment by a blinded board certified radiologist
3 secondary outcomes
Post-operative Activity Recovery
Time frame: up to 3 months
Adverse Events
Time frame: 1 week
Quantity of Narcotic Medication
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Emily A Cook, DPM, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac in people with Bunion, run by Beth Israel Deaconess 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 13 inclusion and 35 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: stopped early, as of the sponsor's last update on 21 Aug 2019. 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Oct 2018). 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?
Post-Operative Pain (time frame: Post-Operative Day 2). 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 21 Aug 2019.