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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am pregnant and 18 years or older.
Select...
I am having a cesarean delivery at CFCC, planned or emergency.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at hospital discharge (about post-operative day 5)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at hospital discharge (about post-operative day 5)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total postoperative opioid use
Secondary outcome measures
Antiemetic use at Baseline
Antiemetic use at hospital discharge (about post-operative day 5)
Antiemetic use at post-operative day 1
+13 moreTrial 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
1,738 Previous Clinical Trials
2,149,426 Total Patients Enrolled
1 Trials studying Postoperative Pain
58 Patients Enrolled for Postoperative Pain
Avanos MedicalOTHER
8 Previous Clinical Trials
1,798 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant and 18 years or older.I am having a cesarean delivery at CFCC, planned or emergency.I cannot have spinal or epidural anesthesia.I will be under general anesthesia for a procedure.You have allergies to commonly used anesthetic medications.I am currently on medication for chronic pain that affects opiate receptors.You are currently using drugs like methamphetamines.I am unable to understand or agree to the study's procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Saline
- Group 2: Bupivacaine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being courted for this research project?
"Affirmative. According to the data on clinicaltrials.gov, this medical examination is presently looking for participants and was initially advertised on November 7th 2021 with the most recent alteration made October 3rd 2022. Currently, there are 100 people sought from a single study centre."
Answered by AI
Can individuals over 35 years old be included in this trial?
"The requirements for prospective trial participants necessitate that they be aged 18 to 50. There are 69 studies tailored towards minors, and 375 specifically designed for individuals 65 or older."
Answered by AI
Are enrollees currently being accepted for this experiment?
"Data found on clinicaltrials.gov suggests that the trial currently seeks participants, having been posted on November 7th 2021 and updated as recently as October 3rd 2022."
Answered by AI
Who is the target demographic for this medical experiment?
"To meet the eligibility requirements for this trial, potential participants must have delivered through cesarean section and be between 18 to 50 years old. A total of 100 candidates are being accepted into the study."
Answered by AI
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