Post-operative Cesarean Trial of Pain Control

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Cesarean Section; Post-operative Pain

Treatments: Device: ON-Q Pump® with continuous infusion of bupivacaine; Device: ON-Q Pump® with continuous infusion of saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05131178

21-2810

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant patients 18 years of age or older
• Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC

Exclusion criteria

• 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
• Inability to consent to study procedures
• Patient receiving general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Saline

Placebo Comparator group

Description:

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

Treatment:

Device: ON-Q Pump® with continuous infusion of saline

Bupivacaine

Experimental group

Description:

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

Treatment:

Device: ON-Q Pump® with continuous infusion of bupivacaine