Arthrodesis
Conditions
Keywords
big toe arthrodesis, big toe, joint fusion
Brief 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.
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.
Interventions
DRUGOxycodone
Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
DRUGKetorolac
Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.
Sponsors
Medstar Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery. | 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. | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery | Approximately 90 days after surgery (or until 3-month post-op visit is completed) | To study if postop ketorolac affects bone fusion. This will be assessed by comparing the routine x-rays collected at the baseline visit to the routine x-rays taken at the 3-month postop visit. |
Countries
United States
Contacts
Primary ContactAmy Loveland
Backup ContactCrisanto Macaraeg
Outcome results
None listed