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Post-operative Cesarean Trial of Pain Control

Recruiting
18 - 50 years of age
Female
Phase N/A

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Overview

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

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

Study details

Post-operative Pain, Cesarean Section

NCT05131178

University of Colorado, Denver

14 April 2024

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