Ketorolac vs Oxycodone for Great Toe Arthrodesis

Phase 1

Recruiting

• Conditions: Arthrodesis
• Interventions: Drug: Oxycodone; Drug: Ketorolac

• Registration Number: NCT05054868
• Lead Sponsor: Medstar Health Research Institute

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2020-04-14
• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-09-17
• Study First Posted: 2021-09-23
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (Control group) - Oxycodone only	Oxycodone	Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).
Group 2 (Treatment group) - Oxycodone and Ketorolac	Ketorolac	Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.
Group 2 (Treatment group) - Oxycodone and Ketorolac	Oxycodone	Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.

Primary Outcome Measures

Name	Time	Method
Quantitative pain management - measured using a study survey.	14 days after the surgery	To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. The survey will ask the following set of questions-; * number of pills (oxycodone and/or ketorolac) consumed; * if the pain medicine(s) needed to be refilled; * discontinuation date \& reason; * side effects, if any; * the effectiveness of the pain medicine(s); * preference for ketorolac or oxycodone, if applicable
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after surgery.	From baseline to 14 days after the surgery	To study if postop ketorolac provides effective pain relief and helps reduce the need to take oxycodone. Participants will complete a short survey on Days 3, 7, and 14 after surgery. Participants will be asked to provide VAS pain scores, on a scale of 1-10, for the past 24 hours on Days 3, 7, and 14 after surgery.

Trial Locations

Locations (1)

Amy Loveland; 🇺🇸 Baltimore, Maryland, United States