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ESP Block for Post-Cesarean Pain
Phase 4
Waitlist Available
Led By Ashraf S Habib, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-48 hours
Awards & highlights
Study Summary
This trial will explore if a nerve block reduces the need for post-C-section painkillers in women receiving multimodal pain relief.
Who is the study for?
This trial is for women aged 18 or older, with a full-term pregnancy (37-42 weeks), scheduled for an elective cesarean delivery. They should be in good health as defined by specific medical standards (ASA II or III). Women can't join if they've had more than two previous cesareans, are significantly overweight before pregnancy, need additional surgery besides tubal ligation, use opioids regularly due to chronic pain, or have any condition that might make them unstable after surgery.Check my eligibility
What is being tested?
The study is testing the effectiveness of Erector Spinae Plane block using liposomal bupivacaine for pain relief after cesarean delivery compared to past patients who didn't receive this block but had similar pain management. It's a case control study with both prospective and retrospective components involving 30 subjects in the new treatment group and matching them with 120 historical controls.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, potential nerve damage risks associated with regional anesthesia blocks like numbness or weakness, allergic reactions to bupivacaine such as itching or rash, and systemic effects including low blood pressure or heart rate changes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative oxycodone consumption 0- 48 hours after cesarean delivery
Secondary outcome measures
Area under the curve (AUC) of visual analog scale (VAS) pain intensity scores
Need for rescue antiemetics
Need for rescue antipruritics
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ESP BlockExperimental Treatment3 Interventions
Standard of care analgesic regimen with ESP Block
Group II: ControlActive Control1 Intervention
Standard of care analgesic regimen
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bupivacaine
2013
Completed Phase 4
~1510
Erector Spinae Plane (ESP) Block
2023
Completed Phase 4
~360
bupivacaine liposome injectable suspension
2016
Completed Phase 4
~710
Find a Location
Who is running the clinical trial?
Duke UniversityLead Sponsor
2,365 Previous Clinical Trials
3,420,490 Total Patients Enrolled
Ashraf S Habib, MDPrincipal InvestigatorDuke University Hospital
4 Previous Clinical Trials
176 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- During surgery, if any serious medical issues arise such as excessive bleeding or severe infection that could make you unwell or make it difficult for you to recover after surgery, you will not be eligible to participate.You have long-term pain or are taking opioids for a long period.You have received at least three previous courses of treatment for your condition.You have an allergy or medical condition that prevents you from taking any part of the pain management plan.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: ESP Block
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
What safety measures have been implemented for ESP Block usage?
"Due to the fact that ESP Block is now in Phase 4, there is strong evidence of its safety, leading our team at Power to rate it a 3 on their scale."
Answered by AI
Are there open slots for enrollment into this research trial?
"The information on clinicaltrials.gov attests to the fact that no patients are being recruited for this trial presently, even though it was initially posted January 1st 2023 and edited December 16th 2022. Fortunately, there is a plethora of other medical studies actively soliciting participants at present."
Answered by AI
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