RECRUITING

Post-operative Cesarean Trial of Pain Control

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-11-07
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05131178

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant patients 18 years of age or older
  2. * Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
  1. * Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination
  2. * Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone)
  3. * Contraindication to neuraxial anesthesia
  4. * Known allergies to common anesthetic medications
  5. * Inability to consent to study procedures
  6. * Patient receiving general anesthesia

Contacts and Locations

Study Contact

Clinical Research Coordinator
CONTACT
(855) 413-3825
Halley.Isberg@childrenscolorado.org

Principal Investigator

Michael Zaretsky, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado - Colorado Fetal Care Center

Study Locations (Sites)

Children's Hospital Colorado
Aurora, Colorado, 80011
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Michael Zaretsky, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Colorado - Colorado Fetal Care Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-07
Study Completion Date2024-12

Study Record Updates

Study Start Date2021-11-07
Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

  • Post-operative Pain
  • Cesarean Section