Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion
Overview
- Phase
- Phase 3
- Intervention
- Ketorolac Pill
- Conditions
- Ketorolac
- Sponsor
- Rothman Institute Orthopaedics
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Postoperative Pain
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Intervention: Ketorolac Pill
Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Intervention: great toe (1st metatarsophalangeal joint) fusion
Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Intervention: IV Ketorolac
Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Intervention: 5/325mg Oxycodone-Acetaminophen
Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Intervention: Aspirin 81Mg Ec Tab
No Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain
Intervention: great toe (1st metatarsophalangeal joint) fusion
No Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain
Intervention: 5/325mg Oxycodone-Acetaminophen
No Ketorolac administration
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain
Intervention: Aspirin 81Mg Ec Tab
Outcomes
Primary Outcomes
Postoperative Pain
Time Frame: 7 days
Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain
Satisfaction with pain management
Time Frame: 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
Time Frame: 7 days
This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)