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Intravenous Lidocaine for Postoperative Pain

Phase 4

Recruiting

Led By Philippe Richebé, MD, PhD

Research Sponsored by Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria Checklist

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

Must have

Colonic surgery

Be older than 18 years old

Must not have

Arrhythmia, abnormal electrocardiographic, antiarrhythmic therapy

Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours

Awards & highlights

All Individual Drugs Already Approved

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study the effects of lidocaine given during surgery on pain and opioid requirements afterwards, as well as the activity of immune cells.

Who is the study for?

This trial is for adults over 18 undergoing laparoscopic colorectal surgery who are generally healthy (ASA I-III) and follow a specific recovery program (ERAS). It's not for those with heart rhythm problems, on certain medications like antiarrhythmics or immunosuppressives, pregnant women, or anyone allergic to lidocaine or hydromorphone.

What is being tested?

The study tests if intravenous lidocaine during surgery can reduce the need for remifentanil (a painkiller) and improve post-surgery pain management. It also looks at how it affects immune function within 48 hours after surgery compared to a placebo.

What are the potential side effects?

Potential side effects of intravenous lidocaine may include changes in heart rhythm, low blood pressure, numbness around the mouth, dizziness, sleepiness, confusion or seizures. These vary from person to person.

Eligibility Criteria

Inclusion Criteria

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

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I have had surgery on my colon.

Exclusion Criteria

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

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I have a heart rhythm problem but am not on medication for it.

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I am not on long-term steroids, NSAIDs, or immunosuppressants.

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I am allergic or intolerant to lidocaine, hydromorphone, or any drugs used around the time of surgery.

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I cannot use hydromorphone pain control after surgery.

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My surgery was changed from keyhole to open surgery while underway.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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

Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.

Secondary study objectives

Assessment of cytokines in plasma

Assessment of rehabilitation scores and cognitive functions

Assessment of total consumption of inhaled anesthetic desflurane in ml

+9 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Drug Has Already Been Approved

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

Pivotal Trial

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

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: intravenous lidocaine (IVL)Experimental Treatment1 Intervention

Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia.

Group II: PlaceboPlacebo Group1 Intervention

Will receive the same volume of normal saline for the entire duration of anesthesia.

0 / 6Eligibility criteria met