Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2021-11-07
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Saline
ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)
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.
Bupivacaine
ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Exclusion Criteria
* 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
18 Years
50 Years
FEMALE
No
Sponsors
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Avanos Medical
OTHER
Children's Hospital Colorado
OTHER
Colorado Fetal Care Center
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Michael Zaretsky, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Colorado - Colorado Fetal Care Center
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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21-2810
Identifier Type: -
Identifier Source: org_study_id
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