Ketorolac vs Oxycodone for Great Toe Arthrodesis

Effect of Ketorolac Administration on Post-operative Narcotic Utilization and Union Rates in Great Toe Arthrodesis

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 Overview

• Status: Recruiting
• Conditions: Arthrodesis
• Intervention / Treatment: Drug: Oxycodone; Drug: Ketorolac

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Amy Loveland; Phone Number: 3015602937; Email: amy.loveland@medstar.net
• Study Contact Backup: Name: Crisanto Macaraeg; Phone Number: 410-261-8218; Email: Crisanto.L.Macaraeg@Medstar.net

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • Amy Loveland
      • Contact: Crisanto Macaraeg; Phone Number: 4102618218; Email: crisanto.l.macaraeg@medstar.net
      • Contact: Amy Loveland; Phone Number: 301-560-2937; Email: amy.loveland@medstar.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 (Control group) - Oxycodone only; Subjects randomized to this group will receive oxycodone for postop pain management (standard of care).	Drug: Oxycodone; Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
Experimental: Group 2 (Treatment group) - Oxycodone and Ketorolac; Subjects randomized to this group will receive oxycodone and ketorolac for postop pain management.	Drug: Oxycodone; Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).; Drug: Ketorolac; Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores - collected at baseline (standard of care) and for the study using a study survey on days 3, 7, and 14 after 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.	From baseline to 14 days after the surgery
Quantitative pain management - measured using a study survey.	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	14 days after the surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery	To study if postop ketorolac affects bone fusion. This will be assessed by comparing the routine x-rays collected at the baseline visit to the routine x-rays taken at the 3-month postop visit.	Approximately 90 days after surgery (or until 3-month post-op visit is completed)

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 12, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: joint fusion; big toe arthrodesis; big toe
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ketorolac; Oxycodone
• Other Study ID Numbers: STUDY00001123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No