Post-operative Cesarean Trial of Pain Control

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05131178
Status
Recruiting
Apply to this trial

Conditions

  • Cesarean Section
  • Post-operative Pain

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • ON-Q Pump® with continuous infusion of bupivacaine — DEVICE
    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.
  • ON-Q Pump® with continuous infusion of saline — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 7, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
May 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

Total postoperative opioid use [ Time Frame: Post-operative day 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80011
Liz Torres
[email protected]
720-777-1661

Find similar trials in Aurora, CO

By research site
Children's Hospital Colorado· Aurora, CO

Related Studies