Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Phase 3

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

• Registration Number: NCT04872283
• Lead Sponsor: Rothman Institute Orthopaedics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-23
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Last Update Submitted: 2021-05-03
• Study First Posted: 2021-05-04
• Last Update Posted: 2021-05-04
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketorolac administration	Ketorolac Pill	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
Ketorolac administration	Aspirin 81Mg Ec Tab	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
No Ketorolac administration	Aspirin 81Mg Ec Tab	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
No Ketorolac administration	great toe (1st metatarsophalangeal joint) fusion	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
No Ketorolac administration	5/325mg Oxycodone-Acetaminophen	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
Ketorolac administration	great toe (1st metatarsophalangeal joint) fusion	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
Ketorolac administration	IV Ketorolac	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
Ketorolac administration	5/325mg Oxycodone-Acetaminophen	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

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States