Your session is about to expire
← Back to Search
Procedure
ESP Block for Inflammatory Bowel Disease
N/A
Recruiting
Led By Naveed Siddiqui, MD
Research Sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ASA physical status I-III
IBD abdominal laparoscopic assisted surgeries under general anesthesia
Must not have
Unstable requiring emergency surgery
Open laparotomies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours, 48 hours and 72 hours postoperatively
Summary
This trial will test the effect of a procedure called an ESP block on patients' recovery after surgery. The study will be conducted on two groups: one will receive the ESP block with anesthetic, and
Who is the study for?
This trial is for patients with Inflammatory Bowel Disease (IBD) who may also have issues with opioid use. Participants should be preparing for surgery and willing to receive an ultrasound-guided ESP block, which is a type of pain management technique.
What is being tested?
The study tests the effectiveness of the Erector Spinae Plane (ESP) block in improving recovery quality and reducing opioid need after surgery. Patients will randomly get either Ropivacaine (anesthetic) or saline solution in their ESP block before surgery.
What are the potential side effects?
Ropivacaine can cause side effects like low blood pressure, nausea, vomiting, dizziness, numbness around the injection site, or allergic reactions. Saline solution generally has minimal to no side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My health is good to moderately impaired.
Select...
I have had laparoscopic surgery for IBD under general anesthesia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need emergency surgery due to my unstable condition.
Select...
I have had open abdominal surgery.
Select...
I cannot communicate in English.
Select...
I am extremely overweight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours, 48 hours and 72 hours postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours, 48 hours and 72 hours postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Quality of Recovery (via QoR-15) total score
Secondary study objectives
Opioid consumption
Opioid related side effects
The hospital LOS
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Intervention groupActive Control1 Intervention
Ultrasound guided bilateral ESP block either with local anesthetic
Group II: Control groupPlacebo Group1 Intervention
Ultrasound guided bilateral ESP block either with normal saline
Find a Location
Who is running the clinical trial?
Samuel Lunenfeld Research Institute, Mount Sinai HospitalLead Sponsor
131 Previous Clinical Trials
11,521 Total Patients Enrolled
Naveed Siddiqui, MDPrincipal InvestigatorAssociate Professor
7 Previous Clinical Trials
665 Total Patients Enrolled