About this trial
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
Qualifiers
Pregnant patients 18 years of age or older
Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Disqualifiers
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
Trial design
Treatments tested in this trial
- ON-Q Pump® with continuous infusion of bupivacaine
- ON-Q Pump® with continuous infusion of saline
Treatment groups
Sponsors and collaborators
University of Colorado, Denver
Lead sponsor
Avanos Medical
Collaborator
Children's Hospital Colorado
Collaborator
Colorado Fetal Care Center
Collaborator