Ketorolac vs Oxycodone for Great Toe Arthrodesis | NCT05054868 | Trialant

Ketorolac vs Oxycodone for Great Toe Arthrodesis | NCT05054868 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Oxycodone	Drug	Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).	Group 1 (Control group) - Oxycodone only

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Contacts/Locations Module

Intervention Browse Module