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Opioid Analgesic

Ibuprofen, acetaminophen, oxycodone for Cesarean Section Complications (ERAS Trial)

Phase < 1
Waitlist Available
Led By Pavan Parikh, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25-72 hours post-op
Awards & highlights

Summary

This trial will test whether or not scheduled medications can reduce the risk of persistent opioid use for women after cesarean delivery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~25-72 hours post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and 25-72 hours post-op for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of morphine milligram equivalents used from 25-72 hours post-op
Patient's morphine milligram equivalent usage from day of discharge to outpatient post-operative visit
Secondary outcome measures
Amount a patient ambulates on post-operative day #2 and #3
Amount of acetaminophen used on post-operative day #2 and #3
Amount of ibuprofen used on post-operative day #2 and #3
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Study GroupExperimental Treatment1 Intervention
Participants will receive ibuprofen 800mg every eight hours and acetaminophen 1000mg every eight hours, given at the same time, along with oxycodone five mg every six hours PRN for breakthrough pain.
Group II: Standard GroupActive Control1 Intervention
Participants will receive current OU standard of care therapy which includes ibuprofen 800mg every eight hours as needed (PRN), acetaminophen 1000mg every eight hours PRN, and oxycodone five mg every six hours PRN.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen, acetaminophen, oxycodone
2020
Completed Early Phase 1
~40

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
457 Previous Clinical Trials
95,722 Total Patients Enrolled
Pavan Parikh, MDPrincipal InvestigatorUniversity of Oklahoma HSC
1 Previous Clinical Trials
52 Total Patients Enrolled
~7 spots leftby Jul 2025