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as needed pain regimen 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: laparoscopic cholecystectomy, laparoscopic appendectomy, laparoscopic ventral/umbilical/incisional hernia repair, open ventral/umbilical/incisional hernia repair, laparoscopic inguinal hernia repair, open inguinal hernia repair, lumpectomy, sentinel lymph node biopsy, lymph node biopsy, mass excision skin or subcutaneous, diagnostic laparoscopy, laparoscopic lysis of adhesions, pilonidal cyst excision, hemorrhoidectomy, anal fissure/sphincterotomy, anal fistulectomy, rectal exam under anesthesia, wound debridement, and wound closure
* Outpatients who are medically eligible to receive the standard post surgery medication protocol (the scheduled pain protocol used in this study).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Summary

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 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

Timeline

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

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.

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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
~60 spots leftby Jul 2026
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