NCT05131178

Post-operative Cesarean Trial of Pain Control

Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-operative Pain
• Cesarean Section

Interventions

Type	Name	Description
DEVICE	ON-Q Pump® with continuous infusion of bupivacaine	270 ml of 0.5 % bupivacaine. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.
DEVICE	ON-Q Pump® with continuous infusion of saline	270 mL of normal saline. The device being used is a fixed flow pump meaning the rate of 2 mL/hour. The pump is connected to the catheter and left in place for up to 4 post-operative days or until the completion of the infusion.

Timeline

• Start date: 2021-11-07
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2021-11-23
• Last updated: 2026-02-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study