NCT04872283

Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ketorolac
• Joint Fusion

Interventions

Type	Name	Description
PROCEDURE	great toe (1st metatarsophalangeal joint) fusion	Great Toe joint fusion surgery
DRUG	IV Ketorolac	Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery
DRUG	Ketorolac Pill	Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain
DRUG	5/325mg 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
DRUG	Aspirin 81Mg Ec Tab	Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)

Timeline

• Start date: 2019-05-23
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-05-04
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study