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Impact of Intravenous Lidocaine During Colorectal Surgery on Pain and Immune Functions

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ClinicalTrials.gov Identifier: NCT03410836
Recruitment Status : Not yet recruiting
First Posted : January 25, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Foundation of Anesthesia and Resuscitation of Quebec
Information provided by (Responsible Party):
Philippe Richebe, Ciusss de L'Est de l'Île de Montréal

Brief Summary:
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.

Condition or disease Intervention/treatment Phase
Intravenous Lidocaine and Immunity Drug: intravenous lidocaine (IVL) Other: Placebo Phase 4

Detailed Description:

Hypothesis: We hypothesize that the intravenous lidocaine (IVL) versus placebo administered during laparoscopic colorectal surgery will allow for: a reduction in intraoperative remifentanil consumption, an improvement in patients' early rehabilitation after surgery, and an enhancement of the immune profile of our patients through an increase in the balance Th1/Th2 and cellular immunity.

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of patients. Randomization into the treatment group or placebo group according to a randomization list for a total number of patients of 60.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The drug administered intraoperatively (intravenous lidocaine or intravenous placebo) will be blinded to patient, anesthesiologist, research nurse for the entire duration of the study.
Primary Purpose: Treatment
Official Title: Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: 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 Comparator: Placebo
Will receive the same volume of normal saline for the entire duration of anesthesia.
Other: Placebo
Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).




Primary Outcome Measures :
  1. 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. [ Time Frame: Intra-operative, 5 hours ]
    Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.


Secondary Outcome Measures :
  1. Evaluation of the number of remifentanil boluses given intraoperatively (n) [ Time Frame: T0 to end of surgery, 5 hours ]
    Evaluation of the number of remifentanil boluses given intraoperatively, based on the intraoperative NOL index from T0 which is the time of the incision

  2. Assessment of total consumption of inhaled anesthetic desflurane in ml [ Time Frame: intra-operative ]
    The Dräger Perseus A500 that we have in each anesthesia room offers the opportunity to get the ml of halogenous gas consumed precisely, and our electronic extraction database will allow to have this data in ml per second and the total at the end of surgery

  3. Evaluation of time for extubation [ Time Frame: post-operative 1 hour ]
    Evaluation of time for extubation after surgery in the operating room

  4. Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration [ Time Frame: in recovery room, 3 hours ]
    Evaluation of the hydromorphone dose in mg used as post-operative titration immediately in the recovery room (PACU) to obtain NRS pain scores < 3/10

  5. Evaluation of the nausea and vomiting scores, 0 to 3 scale [ Time Frame: 48 hours ]
    Evaluation of the nausea and vomiting scores (0 to 3) for the first 48 hours

  6. Evaluation of the length of stay in the recovery room based on the Aldrete scores (Score from 0 to 9) [ Time Frame: in recovery room, 3 hours ]
    Evaluation of the length of stay in the recovery room based on the Aldrete scores (time to be ready to leave the recovery room)

  7. total hydromorphone consumption (mg) after PACU, on wards [ Time Frame: 48 hours ]
    total hydromorphone consumption (mg given by Patient Controlled Analgesia) on wards for 48 hours

  8. Evaluation of the satisfaction of the patient scale 0 to 100 (%) [ Time Frame: 48 hours postoperatively ]
    Evaluation of the satisfaction of the patient as for the management of his pain for 48 hours

  9. Assessment of total hospital duration of stay in hours [ Time Frame: 7 days postoperatively ]
    Assessment of total hospital stay in hours

  10. Evaluation of the time in hours required for the emission of a first gas in hours [ Time Frame: 5 days postoperatively ]
    Evaluation of the time in hours required for the emission of a first gas, a sign of resumption of normal intestinal function

  11. Assessment of rehabilitation scores and cognitive functions [ Time Frame: 2 days ]
    Assessment of rehabilitation scores and cognitive functions at 48h after surgery

  12. Assessment of cytokines in plasma [ Time Frame: 48 hours ]
    Assessment of inflammation parameters by blood sample for 48 hours



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA status I, II or III
  • Patients older than 18 years
  • Colonic surgery
  • Classical management of ERAS program patients in our center

Exclusion Criteria:

  • Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410836


Contacts
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Contact: Philippe Richebé, MD PhD 514-743-6558 philippe.richebe@umontreal.ca
Contact: Nadia Godin, RN 514-525-3400 ext 3193 ngodin.hmr@ssss.gouv.qc.ca

Sponsors and Collaborators
Ciusss de L'Est de l'Île de Montréal
Foundation of Anesthesia and Resuscitation of Quebec
Investigators
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Principal Investigator: Philippe Richebé, MD, PhD CIUSSS Est de l'ile de Montreal
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Responsible Party: Philippe Richebe, Director of Research in Anesthesiology, MD, PhD, Ciusss de L'Est de l'Île de Montréal
ClinicalTrials.gov Identifier: NCT03410836    
Other Study ID Numbers: 2017-1066
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philippe Richebe, Ciusss de L'Est de l'Île de Montréal:
lidocaine
colorectal cancer
laparoscopy surgery
anesthesia
inflammation
cytokine
post-operative immunosuppression
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action