Recruiting

Pain Control

Sponsor:

University of Colorado, Denver

Code:

NCT05131178

Conditions

Post-operative Pain

Cesarean Section

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

ON-Q Pump® with continuous infusion of bupivacaine

ON-Q Pump® with continuous infusion of saline

Study Details

Brief 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.

Conditions

Post-operative Pain

Cesarean Section

Study ID

NCT05131178

Start date

Nov 7, 2021

Status verified date

Feb, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

ON-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.

ON-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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Clinical Research Manager

720-777-7080Kaylene.Ross@childrenscolorado.org

Deion Pena

Deion.pena@childrenscolorado.org

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80011

Contacts

Liz Torres

720-777-1661Elizabeth.Torres@childrenscolorado.org

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-02-06.