Ketorolac, Joint Fusion
Conditions
Brief 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. 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.
Interventions
PROCEDUREgreat toe (1st metatarsophalangeal joint) fusion
Great Toe joint fusion surgery
DRUGIV Ketorolac
Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery
DRUGKetorolac Pill
Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain
DRUG5/325mg Oxycodone-Acetaminophen
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
Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded at enrollment and first made aware to which intervention they were randomized when receiving their postoperative pain medication at outside pharmacies
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 7 days | Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain |
| Satisfaction with pain management | 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 | 7 days | This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always) |
Countries
United States
Outcome results
None listed