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IV Lidocaine for Hernia Repair (PEH Trial)

Phase 4

Recruiting

Led By Paul D Colavita, MD

Research Sponsored by Atrium Health

Eligibility Criteria Checklist

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

Must have

American Association of Anesthesiologists (ASA) scores of I-III

Undergoing elective laparoscopic paraesophageal hernia repair including robotic assisted laparoscopic cases

Must not have

Patients receiving opioid pain medication in the previous week or taking daily medication for chronic pain

Patients with contraindications to sodium channel blockers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial will study the effects of IV lidocaine on post-operative pain control and outcomes in patients undergoing paraesophageal hernia repair, compared to the current standard of care.

Who is the study for?

This trial is for adults over 18 undergoing elective laparoscopic paraesophageal hernia repair. Candidates must have an ASA score of I-III and not be on opioid pain medication or daily chronic pain medication. Exclusions include those with seizure disorders, certain heart conditions, severe kidney disease, recent opioid use, planned additional surgeries, extreme obesity (BMI >40), lidocaine allergies, or contraindications to sodium channel blockers.

What is being tested?

The study tests if IV lidocaine improves postoperative pain control in patients having paraesophageal hernia repairs compared to a placebo. It will assess the effect on recovery outcomes like hospital stay length, complications rates, and quality of life within an Enhanced Recovery After Surgery (ERAS) protocol.

What are the potential side effects?

Potential side effects from IV lidocaine may include symptoms such as dizziness, sleepiness, confusion or clear thinking problems; vision changes; ringing in the ears; numbness around the mouth; tremors; seizures if levels get too high; and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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My health is good to moderate, as rated by an anesthesiologist.

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I am scheduled for a laparoscopic surgery to repair a hernia near my esophagus.

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I am 18 years old or older.

Exclusion Criteria

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

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I have been taking opioid pain medication or daily medication for chronic pain in the last week.

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I cannot take medications that block sodium channels due to health reasons.

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I have end stage kidney disease.

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I have a condition that causes seizures.

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I am planning to have surgery other than PEH repair.

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I have heart rhythm problems or heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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

Day to toleration of diet

Length of Stay

Post-Op Morphine Equivalents

+2 more

Side effects data

From 2019 Phase 4 trial • 86 Patients • NCT03540030

Hospitalization for ileus

mesenteric artery stenosis

100%

80%

60%

40%

20%

Study treatment Arm

Non-Opioid Intervention

Observational

Awards & Highlights

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IV LidocaineExperimental Treatment1 Intervention

100 mg Lidocaine bolus on induction, then an infusion of 1.5 mg/kg/hr to begin prior to incision, run throughout the operation and continues into PACU for 1 hour OR until one 2gm/250mL D5W bag has been infused, whichever occurs first. The Patient will be monitored by nursing staff with the aid of continuous cardiac monitoring in the PACU for at least 30 minutes after the discontinuation of the lidocaine drip.

Group II: PlaceboPlacebo Group1 Intervention

Patients will receive D5W solution at the same volume and rate as the IV lidocaine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IV lidocaine

2016

Completed Phase 4

~90

0 / 9Eligibility criteria met