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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
Patients older than 18 years
Classical management of ERAS program patients in our center
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am older than 18 years.
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I am managed under the ERAS program at this center.
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I have had surgery on my colon.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Assessment of cytokines in plasma
Assessment of rehabilitation scores and cognitive functions
Assessment of total consumption of inhaled anesthetic desflurane in ml
+9 more

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.

Find a Location

Who is running the clinical trial?

Foundation of Anesthesia and Resuscitation of QuebecUNKNOWN
Ciusss de L'Est de l'Île de MontréalLead Sponsor
69 Previous Clinical Trials
5,409 Total Patients Enrolled
Philippe Richebé, MD, PhDPrincipal InvestigatorCIUSSS Est de l'ile de Montreal
3 Previous Clinical Trials
949 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the previous investigations surrounding intravenous lidocaine (IVL) administration?

"Presently, a total of 118 studies are in progress related to intravenous lidocaine (IVL) with 31 trials being conducted at the Phase 3 level. While Calgary, Alberta is home to many clinical trials for IVL, there exists 1094 sites globally running these experiments."

Answered by AI

Is the administration of lidocaine via intravenous infusion sanctioned by the FDA?

"The known safety of IVL led to it receiving a score of 3 on our scale; this Phase 4 trial has been approved for use."

Answered by AI

How many participants have been selected for this research project?

"Affirmative. Clinicaltrials.gov reveals that the research, which was first advertised on April 29th 2019 and has been recently updated on October 1st 2021, is recruiting participants. The medical trial requires 60 individuals at a single site to complete it."

Answered by AI

Are there any remaining slots in this experiment available to participants?

"This research study, originally posted on April 29th 2019, is currently seeking participants. Data hosted on clinicaltrials.gov corroborates this point and confirms that the trial was last updated October 1st 2021."

Answered by AI

How is intravenous lidocaine (IVL) typically employed clinically?

"Cervical Syndrome is commonly managed with the use of Intravenous Lidocaine (IVL). In addition, this form of medication can be used for minor burn relief, post-transplant treatments and to improve bone density."

Answered by AI
~7 spots leftby Dec 2024