Comparing ketorolac and oxycodone for pain relief after big toe surgery
Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis
This study tests if ketorolac can help reduce pain after big toe surgery and lessen the need for oxycodone in adults aged 18 to 75.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05054868 on ClinicalTrials.gov |
What this trial studies
This study investigates whether ketorolac can reduce the need for oxycodone, the standard pain relief medication, following a joint fusion procedure for the great toe. It aims to determine if ketorolac not only alleviates pain but also influences the healing of the bone post-surgery. Participants will be monitored for pain levels and recovery outcomes after receiving either ketorolac or oxycodone. The study focuses on adults aged 18 to 75 undergoing elective great toe arthrodesis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 undergoing elective great toe MTP arthrodesis.
Not a fit: Patients with chronic pain syndromes, diabetes, or those unable to take NSAIDs due to medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective alternative to opioids for pain management, potentially reducing opioid dependency.
How similar studies have performed: Other studies have shown promising results with NSAIDs in reducing opioid use, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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 * 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)
Where this trial is running
Baltimore, Maryland
- Amy Loveland — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: Amy Loveland
- Email: amy.loveland@medstar.net
- Phone: 3015602937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.