RecruitingNot ApplicableNCT05131178

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

Sponsor

University of Colorado, Denver

Enrollment

100 participants

Start Date

Nov 7, 2021

Study Type

INTERVENTIONAL

Conditions

Post Operative Pain Cesarean Section

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

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ON-Q Pump® with continuous infusion of bupivacaine and a medical device called ON-Q Pump® with continuous infusion of saline for people with cesarean section and post operative pain. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEON-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.

DEVICEON-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.