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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of 168 postoperative hours and at 2 weeks after the 168 postoperative hours

Awards & highlights

EXODUS Trial 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.Check my eligibility

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.See study design

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.

EXODUS Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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.

EXODUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and on postop day 4, postop day 7, and at 2 weeks after the 168 postoperative hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Antiemetics use

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

Hospital readmission and ED visits

+12 more

EXODUS 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

~1610

Liposomal bupivacaine

2016

Completed Phase 4

~1970

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hartford HospitalLead Sponsor

133 Previous Clinical Trials

18,882 Total Patients Enrolled

Kevin Finkel, MDPrincipal InvestigatorHartford Hospital

2 Previous Clinical Trials

204 Total Patients Enrolled

Frequently Asked Questions

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

Does this research endeavor include participants greater than 25 years old?

"In order to be qualified for this trial, a patient must provide proof that they are between 18 and 80 years of age."

Answered by AI

What kind of safety profile does RSB LB/B have for individuals who take it?

"The safety profile of RSB LB/B has been evaluated and rated a 3 due to the completion of Phase 4 trials, signifying its approval status."

Answered by AI

Is there an opportunity for me to get involved with this medical study?

"In order to be accepted into the trial, applicants must have aortic disease and fall between 18-80 years of age. A total number of 50 participants are being enrolled."

Answered by AI

Are there opportunities for enrolment in this trial?

"Affirmative, the data listed on clinicaltrials.gov reveals that recruitment is currently underway for this study which was first advertised on October 18th 2023. Its most recent update was made a day later and it aims to enlist 50 patients at one particular site."

Answered by AI

How many individuals are being monitored in this experiment?

"Affirmative, the information available on clinicaltrials.gov reflects that this medical experiment is actively enrolling individuals. It was initially posted on October 18th 2023 and revised a day later. The requirement for volunteers stands at 50 participants from one particular site."

Answered by AI

Recent research and studies

Surgical EndoscopyJournal

Comprehensive Enhanced Recovery Pathway Significantly Reduces Postoperative Length of Stay and Opioid Usage in Elective Laparoscopic Colectomy

Alvarez, Martin P., Katherine E. Foley, D. Mark Zebley, and Steven A. Fassler. 2014. “Comprehensive Enhanced Recovery Pathway Significantly Reduces Postoperative Length of Stay and Opioid Usage in Elective Laparoscopic Colectomy”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-014-4006-8.

clinicaltrials.govStudy

Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters

Kevin Finkel 2023. "Liposomal Bupivacaine/Bupivacaine in RS Blocks vs. Ropivacaine in RS Blocks And Catheters". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05972018.

All > Abdominal Aortic Aneurysm