Post-operative Cesarean Trial of Pain Control

NCT05131178 | Recruiting DMC FDA Device

• 1 other identifier: 21-2810
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid use

  Total postoperative opioid use in morphine equivalents through discharge

  Post-operative day 4

Secondary Outcomes (16)

• Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score

  At hospital discharge (about post-operative day 5)

• Antiemetic use at Baseline

  Baseline

• Antiemetic use at post-operative day 1

  Post-operative day 1

• Antiemetic use at post-operative day 2

  Post-operative day 2

• Antiemetic use at post-operative day 3

  Post-operative day 3

Study Arms (2)

Saline

PLACEBO COMPARATOR

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

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

Bupivacaine

EXPERIMENTAL

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

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

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.

Bupivacaine

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.

Saline

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avanos Medical: collaborator
• Children's Hospital Colorado: collaborator
• Colorado Fetal Care Center: collaborator
• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80011, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Michael Zaretsky, MD

  Children's Hospital Colorado - Colorado Fetal Care Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Manager

CONTACT

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

Deion Pena

CONTACT

Deion.pena@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 23, 2021
• Study Start: November 7, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)