Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ketorolac Joint Fusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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

Study Groups

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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

Group Type ACTIVE_COMPARATOR

great toe (1st metatarsophalangeal joint) fusion

Intervention Type PROCEDURE

Great Toe joint fusion surgery

IV Ketorolac

Intervention Type DRUG

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

Ketorolac Pill

Intervention Type DRUG

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

5/325mg Oxycodone-Acetaminophen

Intervention Type 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

Aspirin 81Mg Ec Tab

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

great toe (1st metatarsophalangeal joint) fusion

Intervention Type PROCEDURE

Great Toe joint fusion surgery

5/325mg Oxycodone-Acetaminophen

Intervention Type 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

Aspirin 81Mg Ec Tab

Intervention Type DRUG

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

Interventions

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great toe (1st metatarsophalangeal joint) fusion

Great Toe joint fusion surgery

Intervention Type PROCEDURE

IV Ketorolac

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

Intervention Type DRUG

Ketorolac Pill

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

Intervention Type 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

Intervention Type DRUG

Aspirin 81Mg Ec Tab

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes