Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

NCT04872283 | Unknown Phase 3 FDA Drug

• 1 other identifier: JONE19D.372
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Ketorolac; Joint Fusion

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain

  7 days

• Satisfaction with pain management

  This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied)

  7 days

• Participant Perception of Pain

  This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)

  7 days

Study Arms (2)

Ketorolac administration

ACTIVE COMPARATOR

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

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

No Ketorolac administration

ACTIVE COMPARATOR

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

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

Interventions

great toe (1st metatarsophalangeal joint) fusion PROCEDURE

Great Toe joint fusion surgery

Ketorolac administration; No Ketorolac administration

IV Ketorolac DRUG

Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery

Ketorolac administration

Ketorolac Pill DRUG

Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain

Ketorolac administration

5/325mg Oxycodone-Acetaminophen DRUG

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

Ketorolac administration; No Ketorolac administration

Aspirin 81Mg Ec Tab DRUG

Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)

Ketorolac administration; No Ketorolac administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Ankylosis

Interventions

Gene Fusion; Ketorolac; oxycodone-acetaminophen; Aspirin

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be blinded at enrollment and first made aware to which intervention they were randomized when receiving their postoperative pain medication at outside pharmacies
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 4, 2021
• Study Start: May 23, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

US (1)