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Local Anesthetic

Epidural vs Local Anesthesia for Post-Surgical Pain Relief

Phase 3
Recruiting
Led By Rebecca L Stone, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals ≥ 18 years of age
Planned laparotomy by the gynecologic oncology service at the sponsor institution.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

Study Summary

This trial is testing whether a local painkiller is as good as a epidural for pain relief after surgery, and whether it is cheaper. It will also study whether the local painkiller has any effect on stress response hormones.

Who is the study for?
This trial is for adults over 18 who are scheduled for open gynecologic surgery. It's not suitable for those with conditions that make epidural analgesia risky, bleeding disorders, infections at the potential epidural site, certain brain pathologies, a history of long-term opioid use, spinal abnormalities, contraindications to liposomal bupivacaine or severe liver disease.Check my eligibility
What is being tested?
The study compares two pain relief methods after open gynecologic surgery: thoracic epidural analgesia (TEA) using bupivacaine and surgical site infiltration with liposomal bupivacaine (LB). The aim is to see if LB is as effective and more cost-efficient than TEA without compromising recovery.See study design
What are the potential side effects?
Possible side effects include discomfort at the injection site, risk of infection from the procedure itself, allergic reactions to medications used in either treatment method (bupivacaine or liposomal bupivacaine), and potential impact on neuroendocrine responses due to surgical stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for abdominal surgery by a cancer specialist at the trial's hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Analgesia as assessed by pain intensity scores on a visual analog scale
Total opioid consumption
Secondary outcome measures
Amount of Vasopressor required
Change in Anti-diuretic hormone (ADH) level
Change in Atrial natriuretic peptide (ANP) level
+23 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: Surgical Site Infiltration with Liposomal BupivacaineExperimental Treatment1 Intervention
Liposomal bupivacaine (LB) surgical site infiltration: A single 20 mL liposomal bupivacaine vial containing 266 mg of free-base bupivacaine will be mixed with 60 mL of 0.25% bupivacaine hydrochloride (HCl) and then diluted in preservative-free sterile 0.9% saline for maximal volume not to exceed 300 mL. Dilution with 0.9% saline will be dependent upon length of surgical incision per protocol. The solution will be injected using 22-gauge needle in equal distribution into the peritoneum, along the fascia and into the subcutaneous tissues of the surgical wound by trained faculty surgeons.
Group II: Arm 1: Thoracic Epidural Analgesia with bupivicaineExperimental Treatment1 Intervention
Thoracic epidural analgesia (TEA): 0.125 % Bupivicaine infusion (5-7 milliliter [mL] per hour) intraoperatively with a 3 mL bolus at the end of the operative procedure just prior to emergence from general anesthesia. Postoperatively 0.0625% Bupivicaine until patient-controlled epidural analgesia (PCEA) pump. PCEA pump 0.0625% bupivacaine at 5-7 mL per hour infusion with a 3 mL q20 minutes demand. PCEA discontinuation with oral tolerance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Liposomal bupivacaine
2016
Completed Phase 4
~1970

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
556 Previous Clinical Trials
32,780 Total Patients Enrolled
Pacira Pharmaceuticals, IncIndustry Sponsor
133 Previous Clinical Trials
13,695 Total Patients Enrolled
Rebecca L Stone, MDPrincipal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Media Library

Liposomal bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04117074 — Phase 3
Pain relief Research Study Groups: Arm 2: Surgical Site Infiltration with Liposomal Bupivacaine, Arm 1: Thoracic Epidural Analgesia with bupivicaine
Pain relief Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT04117074 — Phase 3
Liposomal bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04117074 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the odds of being selected for this opportunity?

"That is correct. The information available on clinicaltrials.gov shows that this trial is still recruiting patients. The first posting was on April 14th, 2021 and the most recent update was on May 6th, 2022. They are looking for 100 individuals to participate at 2 different research sites."

Answered by AI

Is it possible to sign up for this experiment?

"That is correct. The clinical trial in question, which was posted on April 14th 2021 and updated on May 6th 2022, is still recruiting patients. They are looking for a total of 100 participants that will be split between 2 locations."

Answered by AI

What medical procedures utilize Liposomal bupivacaine?

"Liposomal bupivacaine can be used to ameliorate the symptoms of permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

Are there other case studies available that concern Liposomal bupivacaine?

"There are 124 ongoing clinical trials investigating the efficacy of Liposomal bupivacaine. Of these, 21 have progressed to Phase 3 testing. Many of the studies are based out of Philadelphia, but there are a total of 169 different research sites across the globe."

Answered by AI

Does the FDA recognize Liposomal bupivacaine as a safe medication?

"Liposomal bupivacaine has been shown to be safe in multiple clinical trials, so it received a score of 3."

Answered by AI

Who else is applying?

What site did they apply to?
Johns Hopkins Hospital
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I’m currently looking into areas that can better handle my concern over pain control for my gynecological surgery.
PatientReceived 1 prior treatment
~12 spots leftby Sep 2024