Ketorolac vs Oxycodone for Great Toe Arthrodesis

MedStar Health

Status and phase: Enrolling; Phase 1

Conditions: Arthrodesis

Treatments: Drug: Ketorolac; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT05054868

STUDY00001123

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group 1 (Control group) - Oxycodone only

Active Comparator group

Description:

Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).

Treatment:

Drug: Oxycodone

Group 2 (Treatment group) - Oxycodone and Ketorolac

Experimental group

Description:

Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.

Treatment:

Drug: Ketorolac

Drug: Oxycodone