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Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

NCT04872283 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2021-05-04

No results posted yet for this study

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

Interventions

PROCEDURE

great toe (1st metatarsophalangeal joint) fusion

Great Toe joint fusion surgery

DRUG

IV Ketorolac

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

DRUG

Ketorolac Pill

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

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

DRUG

Aspirin 81Mg Ec Tab

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

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2021-12-31
Completion
2021-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04872283 on ClinicalTrials.gov