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Local Anesthetic

Local Anesthesia for Abdominal Surgery Pain Management (CLEVELAND Trial)

Phase 3

Recruiting

Led By Alparslan Turan, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

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

Must have

Expected requirement for parenteral opioids for at least 72 hours for postoperative pain

Scheduled for elective open or laparoscopic-assisted abdominal surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

CLEVELAND Trial Summary

This trial will compare the efficacy of three different types of local anesthesia for major abdominal surgery in terms of pain relief and duration of effect.

Who is the study for?

This trial is for adults aged 18-85 scheduled for major abdominal surgery, who will stay in the hospital at least three nights and need opioids post-surgery. They must be able to use IV pain control systems and not have liver or kidney disease, be pregnant/breastfeeding, on certain blood thinners, have high surgical port sites, weigh under 50 kg, or be allergic to bupivacaine.Check my eligibility

What is being tested?

The study tests the effectiveness of TAP blocks using liposomal bupivacaine (a long-lasting numbing medication), plain bupivacaine (standard numbing medication), or saline (placebo) in managing pain after abdominal surgery. It measures how long the pain relief lasts, opioid use, and patient-reported pain levels over up to 72 hours.See study design

What are the potential side effects?

Potential side effects may include reactions at the injection site like swelling or infection; numbness beyond desired areas; toxicity from local anesthetics leading to symptoms such as ringing ears, metallic taste in mouth, numbness around mouth or tongue tip.

CLEVELAND Trial Eligibility Criteria

Inclusion Criteria

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

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I will need strong painkillers through an IV for at least 3 days after surgery.

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I am scheduled for elective surgery in my abdomen.

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My health is good to moderately impaired.

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I am between 18 and 85 years old.

CLEVELAND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 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

Time to return of sensation

Secondary outcome measures

Opioid Consumption

CLEVELAND Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: liposomal bupivacaineActive Control1 Intervention

40 ml of plain bupivacaine 0.25% will be mixed with 20 ml liposomal bupivacaine and 20 ml of saline. 20 ml of the mix will be injected at each location of the 4-quadrant TAP block.

Group II: plain bupivacaineActive Control1 Intervention

50 ml of plain bupivacaine 0.5% will be combined with 30 ml of normal saline making a total of 80 ml. 20 ml will be injected at each location of the 4-quadrant TAP block.

Group III: Normal SalinePlacebo Group1 Intervention

patients will receive total of 80 ml of normal saline, injected 20 ml in each of the four-quadrant sites.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,027 Previous Clinical Trials

1,364,041 Total Patients Enrolled

Alparslan Turan, MDPrincipal InvestigatorThe Cleveland Clinic

7 Previous Clinical Trials

5,087 Total Patients Enrolled

Media Library

Liposomal bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04685876 — Phase 3

Abdominal Surgery Research Study Groups: liposomal bupivacaine, plain bupivacaine, Normal Saline

Abdominal Surgery Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT04685876 — Phase 3

Liposomal bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04685876 — Phase 3

Frequently Asked Questions

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

How is liposomal bupivacaine most often used?

"Liposomal bupivacaine is a medication that is used to treat a number of different conditions, including permphigus, acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Who would be able to join this clinical trial and see if the medication works for them?

"Researchers conducting this study need 237 participants that have undergone abdominal surgery, are between 18 and 85 years old, and meet the following additional conditions: a minimum hospital stay of three nights, the ability to use an IV PCA system, and the surgery must have been elective."

Answered by AI

What are the most recent scientific papers published on liposomal bupivacaine?

"At the moment, there are 124 trials underway that are researching liposomal bupivacaine. 21 of those active clinical trials are in Phase 3. Although the many studies for liposomal bupivacaine are primarily based in Philadelphia, Pennsylvania, there are a total of 169 locations running studies for this treatment."

Answered by AI

Does liposomal bupivacaine increase the risk for adverse effects?

"There is both prior clinical data suggesting efficacy as well as multiple rounds of data collected on safety, so our team has rated the safety of liposomal bupivacaine as a 3."

Answered by AI

Does this drug testing include elderly individuals?

"According to the eligibility requirements listed on the clinical trial's website, applicants must be between 18-85 years old to be considered. There are 15 similar trials for people under 18 and 115 for people over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparing TAP Blocks Bupivacaine, and Placebo for Plane

2021. "Comparing TAP Blocks Bupivacaine, and Placebo for Plane". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04685876.

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