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Local Anesthetic

ON-Q Pump® Pain Control for Post-Cesarean Pain

N/A
Recruiting
Led By Michael Zaretsky, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant patients 18 years of age or older
Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC
Must not have
Contraindication to neuraxial anesthesia
Patient receiving general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline

Summary

This trial plans to study postoperative pain management after cesarean deliveries. The study will compare the use of bupivacaine (treatment) versus saline (placebo) groups.

Who is the study for?
This trial is for pregnant patients aged 18 or older who are undergoing scheduled or unscheduled C-sections at the Colorado Fetal Care Center. It's not for those with chronic pain treatment involving opiates, inability to consent, general anesthesia during delivery, active substance abuse, contraindications to spinal anesthesia, or allergies to anesthetic meds.
What is being tested?
The study compares two post-C-section pain management methods: one uses the ON-Q Pump® to deliver bupivacaine (a local anesthetic), and the other uses the same pump but with saline (placebo). The goal is to see which method leads to lower opioid use after surgery.
What are the potential side effects?
Possible side effects include reactions at the infusion site due to bupivacaine such as numbness, weakness, tingling sensations. There may also be a risk of low blood pressure or heart complications if bupivacaine spreads beyond the intended area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am pregnant and 18 years or older.
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I am having a cesarean delivery at CFCC, planned or emergency.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot have spinal or epidural anesthesia.
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I will be under general anesthesia for a procedure.
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I am currently on medication for chronic pain that affects opiate receptors.
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I am unable to understand or agree to the study's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge (about post-operative day 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge (about post-operative day 5) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Total postoperative opioid use
Secondary study objectives
Antiemetic use at Baseline
Antiemetic use at hospital discharge (about post-operative day 5)
Antiemetic use at post-operative day 1
+13 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BupivacaineExperimental Treatment1 Intervention
ON-Q Pump® with continuous infusion of bupivacaine (270 ml of 0.5 % bupivacaine)
Group II: SalinePlacebo Group1 Intervention
ON-Q Pump® with continuous infusion of saline (270 mL of normal saline)

Find a Location

Who is running the clinical trial?

Colorado Fetal Care CenterUNKNOWN
University of Colorado, DenverLead Sponsor
1,806 Previous Clinical Trials
2,822,777 Total Patients Enrolled
Avanos MedicalOTHER
8 Previous Clinical Trials
1,798 Total Patients Enrolled

Media Library

Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05131178 — N/A
Cesarean Section Research Study Groups: Saline, Bupivacaine
Cesarean Section Clinical Trial 2023: Bupivacaine Highlights & Side Effects. Trial Name: NCT05131178 — N/A
Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05131178 — N/A
~0 spots leftby Dec 2024
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