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Scheduled vs As-Needed Pain Medication for Postoperative Pain
Phase 4
Waitlist Available
Led By Kelly Van Fossen, DO
Research Sponsored by Cape Fear Valley Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Any outpatient surgeries performed at Cape Fear Valley Medical Center by Dr. Van Fossen during the duration of the study, including a variety of procedures such as laparoscopic cholecystectomy and hernia repairs
Age 18-65
Must not have
Participants who are not fluent in English
Participants with stage 3 Chronic Kidney Disease or higher
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial aims to see if it's possible to do a randomized controlled trial and to compare how well a scheduled pain medication plan works for pain control compared to taking pain medication only when needed for people having
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include stomach upset or bleeding from Motrin, and drowsiness, nausea, constipation, or addiction risk from narcotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will have outpatient surgery by Dr. Van Fossen at Cape Fear Valley Medical Center.
Select...
I am between 18 and 65 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not fluent in English.
Select...
My kidney function is moderately to severely reduced.
Select...
I am on long-term pain medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Feasibility of trial
Secondary study objectives
Estimate of effect size pain control
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: as needed pain regimenExperimental Treatment1 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 regimenActive Control1 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.
Find a Location
Who is running the clinical trial?
Cape Fear Valley Health SystemLead Sponsor
1 Previous Clinical Trials
125 Total Patients Enrolled
Kelly Van Fossen, DOPrincipal InvestigatorCape Fear Valley Health