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Exparel vs. Bupivacaine for Postoperative Pain After Hernia Surgery
Phase < 1
Recruiting
Research Sponsored by Leslie Son
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Have a ventral or inguinal hernia requiring surgical repair
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 1 week post-operation
Awards & highlights
Study Summary
This trial found that Exparel provides superior postoperative pain control compared to bupivacaine alone in minimally invasive ventral and inguinal hernia repair patients.
Who is the study for?
This trial is for adults over 18 with ventral or inguinal hernias needing surgery. It's not for those under 18, chronic pain patients, individuals with very large (>10 cm) or small (<4 cm) defects, allergies to bupivacaine, recurrent hernia history, emergency surgeries, other concurrent surgeries, heavy alcohol users, if the procedure turns open surgery, people weighing less than 50kg or with a BMI over 45.Check my eligibility
What is being tested?
The study tests two types of TAP blocks in minimally invasive hernia repairs: one using Exparel (Liposomal Bupivacaine), and the other using Marcaine (Bupivacaine). Patients are randomly assigned to receive either treatment to compare postoperative pain control effectiveness.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like swelling and redness; nerve damage symptoms such as numbness or weakness; and systemic effects like nausea or heart rhythm disturbances due to local anesthetics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I need surgery for a hernia in my abdomen or groin area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 1 week post-operation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 1 week post-operation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Subjective Pain Scores using Visual Analog Scale (VAS)
Secondary outcome measures
Opioids Used Post-Operatively compared in anesthesia arms
Opioids Used Post-Operatively related to Hernia Size and Surgical Time
Trial Design
2Treatment groups
Active Control
Group I: Liposomal Bupivacaine (Exparel)Active Control1 Intervention
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
Group II: Bupivacaine (Marcaine)Active Control1 Intervention
The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.
Find a Location
Who is running the clinical trial?
Our Lady of the Lake HospitalOTHER
12 Previous Clinical Trials
639 Total Patients Enrolled
Leslie SonLead Sponsor
Our Lady of the Lake Regional Medical CenterOTHER
5 Previous Clinical Trials
269 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My bupivacaine is mixed with other anesthetics.I have had a TAP block, but not right before my procedure.You have a defect that is smaller than 4 centimeters.I am undergoing or scheduled for another surgery.My surgery might change from minimally invasive to open surgery.I have had hernias come back after treatment.My BMI is over 45.You are allergic to bupivacaine.I am under 18 years old.I have had liver or kidney problems in the past.I had emergency surgery due to an injury.History of alcohol abuse.I am 18 years old or older.People with long-lasting pain.I have a wound or defect larger than 10 cm across.My weight is less than 50kg.I need surgery for a hernia in my abdomen or groin area.
Research Study Groups:
This trial has the following groups:- Group 1: Liposomal Bupivacaine (Exparel)
- Group 2: Bupivacaine (Marcaine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 invited to participate in this scientific investigation?
"Affirmative, the data hosted on clinicaltrials.gov suggests that this trial is currently recruiting patients for participation. This medical experiment was initially posted on March 1st 2022 and has been modified as recently as April 19th 2022. Approximately 200 individuals from a single location are needed to take part in the study."
Answered by AI
What other research initiatives have been implemented to evaluate Liposomal Bupivacaine (Exparel)?
"Currently, the clinical trial landscape for Liposomal Bupivacaine (Exparel) includes 110 active studies with 18 trials in Phase 3. Philadelphia, Pennsylvania hosts many of these experiments but there are also 147 other locations where such research is taking place."
Answered by AI
Are participants sought for this ongoing trial?
"Indeed, the information available on clinicaltrials.gov signifies that this medical experiment is soliciting enrolment. It was first published in March 1st 2022 and underwent its last revision on April 19th of the same year. This study seeks to enroll up to 200 patients from a single site."
Answered by AI
In what clinical scenarios is Liposomal Bupivacaine (Exparel) regularly prescribed?
"Liposomal Bupivacaine (Exparel) is frequently prescribed for permphigus patients. It can also provide relief to individuals dealing with acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell related issues."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
Karl LeBlanc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been looking for relief from this hernia that I have. It does need to be removed and I am trying to locate someone who can help me. I have no insurance and this hernia is keeping me from working and my quality of life is not where it should be. Can you please help me or tell me who can? Thank You!
PatientReceived 1 prior treatment
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