Ketorolac vs Oxycodone for Great Toe Arthrodesis

  • STATUS
    Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    40
  • sponsor
    Medstar Health Research Institute
Updated on 20 June 2022
Accepts healthy volunteers

Summary

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Description

This study reviews if taking ketorolac, after a joint fusion procedure, can decrease the need for taking oxycodone (standard of care) for pain relief. The study also investigates if ketorolac affects bone healing after surgery.

Details
Condition Arthrodesis
Treatment ketorolac, Oxycodone
Clinical Study IdentifierNCT05054868
SponsorMedstar Health Research Institute
Last Modified on20 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 - 75 years
Women of childbearing potential must have a negative serum or urine pregnancy test results within 24 hours before the first dose of ketorolac
Primary elective great toe MTP arthrodesis (CPT 28750). Other forefoot procedures often performed in conjunction with toe fusion will be included (CPT codes 28308, 28285, 28270)

Exclusion Criteria

Chronic pain syndrome, CRPS or fibromyalgia
Revision procedures
Use of allograft bone at the fusion site
Tobacco use
Diabetes
Narcotic abuse or IV drug abuse
Any CPT codes involving the midfoot, hindfoot, and/or ankle
Unable to take NSAIDs secondary to medical comorbidities such as kidney disease (impaired renal function with CrCl ≤ 50 ml/min) or gastric ulcers
Weight < 50 kg
Does not speak or read English
If pregnant or planning to become pregnant or breastfeeding
Non-independent dweller (prisoner)
Clear my responses

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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