Local Anesthesia for Abdominal Surgery Pain Management
(CLEVELAND Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAlparslan Turan, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: The Cleveland Clinic

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The study will prospectively compare the analgesic efficacy of TAP blocks with liposomal bupivacaine, plain bupivacaine, and placebo in patients who are scheduled for major abdominal surgery. The primary aim is to assess the duration of the local analgesia (determined by pinprick and cold) in all four quadrants. Comparing opioid consumption and pain scores is a secondary aim. All aims will be assessed over 72 hours or the duration of hospitalization if shorter.

Eligibility Criteria

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.

Inclusion Criteria

Written informed consent

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

I am scheduled for elective surgery in my abdomen.

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Exclusion Criteria

I have had surgery involving high port sites.

You are allergic to bupivacaine or have had a bad reaction to it in the past.

I weigh less than 50 kg.

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Treatment Details

Interventions

Liposomal bupivacaine (Local Anesthetic)
Normal saline (Local Anesthetic)
Plain bupivacaine (Local Anesthetic)

Trial OverviewThe 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.

Participant Groups

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.

Liposomal bupivacaine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Exparel for: