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Bupivacaine, Liposomal Bupivacaine, and Ropivacaine for Aortic Disease (EXODUS Trial)

Phase 4

Recruiting

Led By Kevin Finkel, MD

Research Sponsored by Hartford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled for elective vascular surgery with an open mid-abdominal laparotomy incision, including abdominal aortic aneurysm repair surgery (AAA), mesenteric artery bypass surgery, and aortobifemoral bypass surgery for aortic occlusive disease

Patients aged 18-80 years

Must not have

Patients with distant metastatic cancers (e.g. bone, lung, brain) confirmed by CT scan

Weight < 40 kg, as a combination of 20 mL of Bupivacaine 0.25% with 30 mL of LB is greater than the maximal dose allowed, given concern for local anesthetic toxicity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial will compare single shot and continuous post-op pain relief to see which works best for abdominal surgery.

Who is the study for?

This trial is for adults aged 18-80 undergoing elective vascular surgery with an open mid-abdominal incision. Candidates must speak/read English, have an ASA score I-IV, and not be on high-dose opioids or have chronic pain syndrome. Exclusions include emergency surgeries, allergies to local anesthetics, substance abuse within 3 months, and certain medical conditions.

What is being tested?

The study compares liposomal bupivacaine/bupivacaine mixture in single shot rectus sheath blocks versus standard care ropivacaine in catheters for post-surgery pain management. It measures pain scores, opioid use, hospital stay duration, patient satisfaction and recovery quality over a period of up to two days after surgery.

What are the potential side effects?

Potential side effects may include reactions at the injection site such as swelling or infection; systemic effects like nausea or dizziness due to local anesthetic toxicity; and rare but serious complications including nerve damage or cardiovascular issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery on the main blood vessels in my abdomen.

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I am between 18 and 80 years old.

Exclusion Criteria

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

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My cancer has spread to distant parts like bone, lung, or brain.

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I weigh less than 40 kg.

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I can receive pain medication through a catheter after surgery without issues.

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I have been using strong painkillers regularly for the last month.

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I need emergency surgery to repair my blood vessels.

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I have not been hospitalized for severe symptoms like intense stomach pain or a burst blood vessel.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 168 postoperative hours and at 2 weeks after discharge

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 168 postoperative hours and at 2 weeks after discharge

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 168 postoperative hours and at 2 weeks after discharge for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The maximum, average, minimum, and current pain scores at the end of the period 24-48 post-op hours

Secondary study objectives

Antiemetics use

Hospital and Intensive Care Unit (ICU) length of stay (LOS)

Hospital readmission and ED visits

+12 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RSB LB/BExperimental Treatment2 Interventions

Rectus Sheath Block: Total 60mL: (20mL 1.3% LB + 30mL 0.25% bupivacaine + 10mL NS) (30mL per side)

Group II: RSB/RSC RopivacaineActive Control1 Intervention

Rectus Sheath Block: Total 60mL of 0.2% ropivacaine (3 vials) (30mL per side) + Rectus Sheath Catheter intermittent hourly boluses of 0.2% ropivacaine 10mL/hr per side

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bupivacain

2022

Completed Phase 4

~1640

Liposomal bupivacaine

2016

Completed Phase 4

~1970