Skip to main content
Clinical Trials/NCT04872283
NCT04872283
Unknown
Phase 3

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

Rothman Institute Orthopaedics1 site in 1 country140 target enrollmentMay 23, 2019

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2019
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

Loading locations...

Similar Trials