Post-operative Cesarean Trial of Pain Control

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Post-operative Pain
• Intervention / Treatment: Device: ON-Q Pump® with continuous infusion of saline; Device: ON-Q Pump® with continuous infusion of bupivacaine

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Manager; Phone Number: 720-777-7080; Email: Kaylene.Ross@childrenscolorado.org
• Study Contact Backup: Name: Deion Pena; Email: Deion.pena@childrenscolorado.org

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Recruiting
      • Children's Hospital Colorado
      • Contact: Liz Torres; Phone Number: 720-777-1661; Email: Elizabeth.Torres@childrenscolorado.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline; ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)	Device: 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.
Experimental: Bupivacaine; ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total postoperative opioid use	Total postoperative opioid use in morphine equivalents through discharge	Post-operative day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction survey with Visual Analog Scale (VAS) Pain Score	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	At hospital discharge (about post-operative day 5)
Antiemetic use at Baseline	Daily antiemetic use by number of doses through discharge	Baseline
Antiemetic use at post-operative day 1	Daily antiemetic use by number of doses through discharge	Post-operative day 1
Antiemetic use at post-operative day 2	Daily antiemetic use by number of doses through discharge	Post-operative day 2
Antiemetic use at post-operative day 3	Daily antiemetic use by number of doses through discharge	Post-operative day 3
Antiemetic use at post-operative day 4	Daily antiemetic use by number of doses through discharge	Post-operative day 4
Antiemetic use at hospital discharge (about post-operative day 5)	Daily antiemetic use by number of doses through discharge	At hospital discharge (about post-operative day 5)
Visual Analog Scale (VAS) Pain Score at Baseline	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	Baseline
Visual Analog Scale (VAS) Pain Score at post-operative day 1	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	Post-operative day 1
Visual Analog Scale (VAS) Pain Score at post-operative day 2	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	Post-operative day 2
Visual Analog Scale (VAS) Pain Score at post-operative day 3	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	Post-operative day 3
Visual Analog Scale (VAS) Pain Score at post-operative day 4	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" (score of 0) and "worst pain" (score of 100 [100-mm scale]).	Post-operative day 4
Time to advance to regular diet	Time to advance to regular diet through discharge	Up to post-operative day 4
Time to first ambulation	Time to first ambulation	Up to post-operative day 4
Return on bowel function	Return on bowel function (pass gas or bowel movement)	Up to post-operative day 4
Edinburgh Depression scale at hospital discharge (about post-operative day 5)	The 10-item Edinburgh Depression Scale (EDS) measures depressive symptoms. It includes three sub-scales: anhedonia, anxiety and depression. Possible total scores range from 0 to 30, with higher scores indicating more depressive symptoms and a worse outcome.	At hospital discharge (about post-operative day 5)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Children's Hospital Colorado; Avanos Medical; Colorado Fetal Care Center
• Investigators: Principal Investigator: Michael Zaretsky, MD, Children's Hospital Colorado - Colorado Fetal Care Center

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 21-2810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes