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NCT05131178 · ClinicalTrials.gov registry record · NA
Post-operative Cesarean Trial of Pain Control
A NA study of Post Operative Pain and Cesarean Section, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05131178 is a NA study of Post Operative Pain and Cesarean Section that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05131178, a NA study of Post Operative Pain and Cesarean Section, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE ON-Q Pump® with continuous infusion of bupivacaine
- DEVICE ON-Q Pump® with continuous infusion of saline
Study Locations (1)
Colorado
- Children's Hospital Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-11-07 |
| Est. Completion | 2027-05 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05131178
The ClinicalTrials.gov registry entry for NCT05131178 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 56 other Post Operative Pain trials with a reported enrollment target (57% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Post Operative Pain appearing as the primary indexed condition, and to 2 interventions - of which ON-Q Pump® with continuous infusion of bupivacaine is the first listed.
NCT05131178 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05131178 about?
NCT05131178 is a clinical study titled "Post-operative Cesarean Trial of 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 follow...
What is the current status of trial NCT05131178?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-11-07. Estimated completion is 2027-05.
What conditions does trial NCT05131178 study?
This clinical trial studies the following conditions: Post Operative Pain, Cesarean Section.
What interventions are being tested in trial NCT05131178?
The interventions under investigation include: ON-Q Pump® with continuous infusion of bupivacaine (DEVICE), ON-Q Pump® with continuous infusion of saline (DEVICE).
Who is sponsoring clinical trial NCT05131178?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05131178 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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