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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

Must not have

Surgeries with high port sites

Weight <50 kg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Pivotal 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.

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.

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.

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.

Exclusion Criteria

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

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I have had surgery involving high port sites.

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I weigh less than 50 kg.

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I cannot have TAP blocks due to my blood thinner medication.

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I am not pregnant or breastfeeding.

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My kidney function is impaired, with creatinine levels twice the normal.

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My liver enzymes are twice the normal level.

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

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

Primary study objectives

Time to return of sensation

Secondary study objectives

Opioid Consumption

Awards & Highlights

Pivotal Trial

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

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 / 10Eligibility criteria met