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Liposomal Bupivacaine for Bowel Surgery Pain Management (TAPLIP 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 laparoscopic colectomy surgery to be performed by one of the 4 colorectal surgeons in the study

English speaking patients

Must not have

Emergency laparoscopic colectomy surgery

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on the day of first postoperative visit, the end of the 6th and 12th postoperative months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the use of a new painkiller, liposomal bupivacaine (Exparel), to regular bupivacaine with other painkillers in patients undergoing laparoscopic colectomy procedures.

Who is the study for?

This trial is for English-speaking patients scheduled for elective laparoscopic colectomy with an ASA score I-IV. Excluded are those with emergency surgery, metastatic cancers, planned multi-organ resection, TAP block contraindications like anatomical abnormalities or infection at the injection site, current colostomies, severe coagulation disorders, underweight (<40kg), chronic opioid use or substance abuse within 3 months.

What is being tested?

The study compares liposomal bupivacaine (Exparel) to regular bupivacaine in bilateral mid-abdominal TAP blocks during laparoscopic colectomy. It's a single-center trial where participants are randomly assigned and triple-blinded to determine which medication provides better pain control.

What are the potential side effects?

Potential side effects include reactions at the injection site such as pain or infection, possible nerve damage from the block procedure itself, and systemic effects of local anesthetics like heart rhythm disturbances or central nervous system 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 a specific colon surgery by a study surgeon.

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I speak English.

Exclusion Criteria

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

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I had emergency surgery to remove part of my colon.

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I weigh less than 40 kg.

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I am scheduled for surgery to remove multiple organs, including part of my colon.

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I currently have a colostomy.

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I have a blood clotting disorder or am on blood thinning medication.

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I've been on strong painkillers or consulted a pain specialist recently due to chronic pain.

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I cannot have TAP or RS blocks due to certain medical reasons like surgery history or infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the day of first postoperative visit, the end of the 6th and 12th postoperative months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the day of first postoperative visit, the end of the 6th and 12th postoperative months

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the day of first postoperative visit, the end of the 6th and 12th postoperative months 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 highest Numerical Pain Scores

Secondary study objectives

All pain scores, mild-moderate-severe.

Block complications

Brief Pain Inventory (Short Form)

+6 more

Awards & Highlights

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.

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal Bupivacaine/Bupivacaine HCLExperimental Treatment2 Interventions

20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Group II: Regular Bupivacaine ArmActive Control1 Intervention

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

0 / 10Eligibility criteria met