Impact of Intravenous Lidocaine During Colorectal Surgery on Pain and Immune Functions
NCT ID: NCT03410836
Last Updated: 2023-10-18
Study Results
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Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2019-04-29
2025-06-30
Brief Summary
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Detailed Description
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Background: so far, IVL was shown to have several properties: analgesic, anti-inflammatory, and anti-hyperalgesic. Its effects on rehabilitation and pain are still controversial except for abdominal surgery. To date, no study evaluated the impact of IVL in colorectal surgery on intraoperative consumption of remifentanil. Postoperative immune suppression is multifactorial and depends on the surgical traumatism, but also on the doses of opioids given during anesthesia. No study evaluated in colorectal surgery the impact of IVL on postoperative cellular immunity and on the risk of cancer recurrence.
Specific Objectives: primary objective: to reduce by 30% the consumption of remifentanil in the IVL group versus the placebo group; secondary objectives: to evaluate the quality of recovery from anesthesia in the OR (awakening and extubation time), in the PACU and on the wards (pain scores, opioid consumption with patient controlled analgesia (PCA), postoperative nausea and vomiting (PONV), transit recovery time, time in PACU and time in hospital), and to evaluate the postoperative inflammatory parameters and adaptative immune functions (Th1/Th2) until postoperative 48h.
Methods: 60 adult patients ASA 1-3 scheduled for elective laparoscopic colorectal surgery will be included in this randomized controlled trial. Randomisation will be into group Control (C) and Lidocaine (IVL). Anesthesia and monitoring will be standardized and accompanied with the monitoring of the depth of anesthesia (BISpectral index, Medtronic) and the depth of analgesia (NoL index, Medasense LTD, recorded on an observational manner). IVL group will blindly be administered intravenous 1.5 mg/kg lidocaine bolus and then 1.5 mg/kg/h until the end of the surgery as previously described. C group will receive the same amount (ml) of placebo. Statistics: a preliminary analysis (idem group C) showed that the total amount of remifentanil given for this type of surgery was 2481+/-985 mcg (duration 141+/-30Min). Considering that we wish to reduce by 30% the remifentanil consumption in the group IVL, the number of patients to be included per group is 30 (alpha 0.05 and beta 20%).
Significance/Importance: this study will evaluate the impact of IVL on intraoperative consumption of remifentanil but also on immune functions after surgery in order to reduce the risk of cancer recurrence. If this study brings positive results, this will lead to a significant change in clinical practice of anesthesia. This is a pilot study on the immune functions, but this might bring very strong results to ask for future grants on the impact of IVL on cancer recurrence.
Study Design: Prospective, randomized controlled study. Subject Population: Adult patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia.
Sample Size: 60 patients will be evaluated in this study. Study Duration: 1 year. Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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intravenous lidocaine (IVL)
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.
intravenous lidocaine (IVL)
lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).
Placebo
Will receive the same volume of normal saline for the entire duration of anesthesia.
Placebo
Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).
Interventions
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intravenous lidocaine (IVL)
lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).
Placebo
Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).
Eligibility Criteria
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Inclusion Criteria
* Patients older than 18 years
* Colonic surgery
* Classical management of ERAS program patients in our center
Exclusion Criteria
* Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours
* conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique
* Pregnant women
* Inability to complete the questions related to this study
* Inability to use hydromorphone postoperative PCA
* Intolerance or allergy to lidocaine, hydromorphone or any other drug that is included in the protocol for perioperative management
Unexpected events leading to the exclusion:
* Difficult unplanned intubation
* Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)
18 Years
ALL
No
Sponsors
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Foundation of Anesthesia and Resuscitation of Quebec
UNKNOWN
Ciusss de L'Est de l'Île de Montréal
OTHER
Responsible Party
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Philippe Richebe
Director of Research in Anesthesiology, MD, PhD
Principal Investigators
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Philippe Richebé, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
CIUSSS Est de l'ile de Montreal
Locations
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Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-1066
Identifier Type: -
Identifier Source: org_study_id
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