Ketorolac vs Oxycodone for Great Toe Arthrodesis

NCT05054868 | Unknown Phase 1 FDA Drug

• 1 other identifier: STUDY00001123
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthrodesis

Keywords

big toe arthrodesis; big toe; joint fusion

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Bone fusion - doctor will review the 3 month postop x-ray to see if the bones have fused at the site of surgery

  Approximately 90 days after surgery (or until 3-month post-op visit is completed)

Study Arms (2)

Group 1 (Control group) - Oxycodone only

ACTIVE COMPARATOR

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

Drug: Oxycodone

Group 2 (Treatment group) - Oxycodone and Ketorolac

EXPERIMENTAL

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

Drug: Oxycodone; Drug: Ketorolac

Interventions

Oxycodone DRUG

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

Group 1 (Control group) - Oxycodone only; Group 2 (Treatment group) - Oxycodone and Ketorolac

Ketorolac DRUG

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

Group 2 (Treatment group) - Oxycodone and Ketorolac

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Amy Loveland

Baltimore, Maryland, 21218, United States

RECRUITING

MeSH Terms

Conditions

Ankylosis

Interventions

Oxycodone; Ketorolac

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring

Central Study Contacts

Amy Loveland

CONTACT

3015602937; amy.loveland@medstar.net

Crisanto Macaraeg

CONTACT

410-261-8218; crisanto.l.macaraeg@medstar.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: September 23, 2021
• Study Start: April 14, 2020
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)