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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.

Must not have

Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions

Individuals with Childs-Pugh Class B or C liver disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have brain conditions causing increased pressure or blocking fluid flow.

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My liver disease is classified as moderate to severe.

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I have a blood clotting disorder.

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I cannot use liposomal bupivacaine due to health reasons.

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I cannot have thoracic epidural pain relief due to health reasons.

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I have an infection where my epidural was placed.

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I have a spine condition, such as abnormal anatomy, fusion surgery, or lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analgesia as assessed by pain intensity scores on a visual analog scale

Total opioid consumption

Secondary study objectives

Amount of Vasopressor required

Change in Anti-diuretic hormone (ADH) level

Change in Atrial natriuretic peptide (ANP) level

+14 more

Awards & Highlights

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.

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

0 / 9Eligibility criteria met