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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 below

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not fluent in English.

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My kidney function is moderately to severely reduced.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

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

0 / 5Eligibility criteria met