NCT05131178 Post-operative Cesarean Trial of Pain Control
| NCT ID | NCT05131178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Colorado, Denver |
| Condition | Post-operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-07 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2021-11-07 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Pregnant patients 18 years of age or older * Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC Exclusion Criteria: * 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
Contact & Investigator
Michael Zaretsky, MD
PRINCIPAL INVESTIGATOR
Children's Hospital Colorado - Colorado Fetal Care Center
Frequently Asked Questions
Who can join the NCT05131178 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Post-operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05131178 currently recruiting?
Yes, NCT05131178 is actively recruiting participants. Contact the research team at Kaylene.Ross@childrenscolorado.org for enrollment information.
Where is the NCT05131178 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05131178 clinical trial?
NCT05131178 is sponsored by University of Colorado, Denver. The principal investigator is Michael Zaretsky, MD at Children's Hospital Colorado - Colorado Fetal Care Center. The trial plans to enroll 100 participants.