Post-operative Cesarean Trial of Pain Control

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Colorado, Denver

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

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Colorado, Denver

Lead sponsor

Avanos Medical

Collaborator

Children's Hospital Colorado

Collaborator

Colorado Fetal Care Center

Collaborator