Scheduled vs As-Needed Pain Medication for Postoperative Pain

Overseen By Kaitlyn Benson, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Cape Fear Valley Health System

Must not be taking: Chronic pain medications

Disqualifiers: Fibromyalgia, Chronic pain, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The aim of this study is to determine feasibility of a randomized controlled trial and estimates of efficacy for pain control of a scheduled pain regimen versus an as needed pain regimen for participants undergoing same day surgery procedures.

Who Is on the Research Team?

Kelly Van Fossen, DO

Principal Investigator

Cape Fear Valley Health

Are You a Good Fit for This Trial?

This trial is for individuals who are experiencing pain after same-day surgery procedures. The study will include those willing to follow a scheduled or as-needed pain medication regimen.

Inclusion Criteria

I am an outpatient and can take standard post-surgery medications.

I will have outpatient surgery by Dr. Van Fossen at Cape Fear Valley Medical Center.

Exclusion Criteria

I am not fluent in English.

My kidney function is moderately to severely reduced.

I am on long-term pain medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive post-operative pain medications including narcotics for 2-3 days and Motrin for 10 days

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Motrin and Narcotic

Trial Overview The study is testing the effectiveness of two pain management strategies: one where patients take Motrin and narcotics on a fixed schedule, and another where they take these medications only when they feel it's necessary.

How Is the Trial Designed?

Group I: as needed pain regimen Experimental Treatment 1 Intervention

This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours as needed for moderate to severe pain (4-10 on numeric rating scale).

Group II: scheduled pain regimen Active Control 1 Intervention

This group will receive post-operative pain medications including narcotics for 2-3 days (Oxycodone/Acetaminophen 5mg/325mg, Hydrocodone/Acetaminophen 5mg/325mg, Hydromorphone 2mg, or Tramadol 50mg) every 4 hours and 800 mg Motrin for 10 days every 8 hours on a fixed time/day schedule.

Who Is Running the Clinical Trial?

Cape Fear Valley Health System

Lead Sponsor

Trials

2

Recruited

220+