ON-Q Pump® Pain Control for Post-Cesarean Pain

Recruiting in Palo Alto (17 mi)

Overseen byMichael Zaretsky, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Colorado, Denver

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of 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.

Research Team

Michael Zaretsky, MD

Principal Investigator

Children's Hospital Colorado - Colorado Fetal Care Center

Eligibility Criteria

This trial is for pregnant patients aged 18 or older who are undergoing scheduled or unscheduled C-sections at the Colorado Fetal Care Center. It's not for those with chronic pain treatment involving opiates, inability to consent, general anesthesia during delivery, active substance abuse, contraindications to spinal anesthesia, or allergies to anesthetic meds.

Inclusion Criteria

I am pregnant and 18 years or older.

I am having a cesarean delivery at CFCC, planned or emergency.

Exclusion Criteria

I cannot have spinal or epidural anesthesia.

I will be under general anesthesia for a procedure.

You have allergies to commonly used anesthetic medications.

See 3 more

Treatment Details

Interventions

Bupivacaine (Local Anesthetic)
ON-Q Pump® (Device)
Saline (Placebo)

Trial OverviewThe study compares two post-C-section pain management methods: one uses the ON-Q Pump® to deliver bupivacaine (a local anesthetic), and the other uses the same pump but with saline (placebo). The goal is to see which method leads to lower opioid use after surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BupivacaineExperimental Treatment1 Intervention

ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)

Group II: SalinePlacebo Group1 Intervention

ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)

Bupivacaine is already approved in Canada for the following indications: