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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• Pregnant patients 18 years of age or older

• Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC

Locations
United States
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Contact Information
Primary
Clinical Research Coordinator
Halley.Isberg@childrenscolorado.org
(855) 413-3825
Time Frame
Start Date: 2021-11-07
Estimated Completion Date: 2024-12
Participants
Target number of participants: 100
Treatments
Placebo_comparator: Saline
ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)
Experimental: Bupivacaine
ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)
Related Therapeutic Areas
Sponsors
Collaborators: Avanos Medical, Children's Hospital Colorado, Colorado Fetal Care Center
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov