Actively Recruiting
Post-operative Cesarean Trial of Pain Control
Led by University of Colorado, Denver · Updated on 2026-02-06
100
Participants Needed
1
Research Sites
285 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
A
Avanos Medical
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study plans to learn more about postoperative pain management after cesarean deliveries (C-sections). As a part of standard of care, the Children's Hospital Colorado's Colorado Fetal Care Center (CFCC) follows the standard Enhanced Recovery After Cesarean (ERAC) guidelines to manage pain following C-section delivery. In addition, the CFCC uses an FDA approved medical device called the ON-Q ® Pump, which continuously delivers local anesthetic medication to control pain in the area of your procedure. The local anesthetic used is bupivacaine, which is FDA approved for use to control local pain after C-sections. The CFCC has found a significant reduction in opioid use after adopting both of these procedures. The study aims to determine if the ERAC protocol or ON-Q ® Pump continuous infusion is responsible for lower opioid use by comparing bupivacaine (treatment) versus saline (placebo) groups.
CONDITIONS
Official Title
Post-operative Cesarean Trial of Pain Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant patients 18 years of age or older
- Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
You will not qualify if you...
- Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
- Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
- Contraindication to neuraxial anesthesia
- Known allergies to common anesthetic medications
- Inability to consent to study procedures
- Patient receiving general anesthesia
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital Colorado
Aurora, Colorado, United States, 80011
Actively Recruiting
Research Team
C
Clinical Research Manager
CONTACT
D
Deion Pena
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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