Ketorolac vs Oxycodone for Great Toe Arthrodesis

Arthrodesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05054868
• Other study ID #: STUDY00001123
• Status: Recruiting
• Phase: Phase 1
• Start date: April 14, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Medstar Health Research Institute
• Contact: Amy Loveland
• Phone: 3015602937
• Email: amy.loveland[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arthrodesis

Intervention

Drug:
• Oxycodone
Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
• Ketorolac
Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.

Locations

Country	Name	City	State
United States	Amy Loveland	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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
Primary	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