Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Rothman Institute Orthopaedics

Status and phase: Unknown; Phase 3

Conditions: Ketorolac; Joint Fusion

Treatments: Drug: Aspirin 81Mg Ec Tab; Procedure: great toe (1st metatarsophalangeal joint) fusion; Drug: Ketorolac Pill; Drug: IV Ketorolac; Drug: 5/325mg Oxycodone-Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04872283

JONE19D.372

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Ketorolac administration

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 81Mg Ec Tab

Drug: IV Ketorolac

Drug: Ketorolac Pill

Drug: 5/325mg Oxycodone-Acetaminophen

Procedure: great toe (1st metatarsophalangeal joint) fusion

No Ketorolac administration

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin 81Mg Ec Tab

Drug: 5/325mg Oxycodone-Acetaminophen

Procedure: great toe (1st metatarsophalangeal joint) fusion