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

NCT03410836 | Unknown Phase 4

• 1 other identifier: 2017-1066
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Lidocaine and Immunity

Keywords

lidocaine; colorectal cancer; laparoscopy surgery; anesthesia; inflammation; cytokine; post-operative immunosuppression

Outcome Measures

Primary Outcomes (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.

  Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.

  Intra-operative, 5 hours

Secondary Outcomes (12)

• Evaluation of the number of remifentanil boluses given intraoperatively (n)

  T0 to end of surgery, 5 hours

• Assessment of total consumption of inhaled anesthetic desflurane in ml

  intra-operative

• Evaluation of time for extubation

  post-operative 1 hour

• Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration

  in recovery room, 3 hours

• Evaluation of the nausea and vomiting scores, 0 to 3 scale

  48 hours

Study Arms (2)

intravenous lidocaine (IVL)

EXPERIMENTAL

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)

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

intravenous lidocaine (IVL) DRUG

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).

intravenous lidocaine (IVL)

Placebo OTHER

Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Difficult unplanned intubation
• Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)

Sponsors & Collaborators

• Ciusss de L'Est de l'Île de Montréal: lead
• Foundation of Anesthesia and Resuscitation of Quebec: collaborator

Study Sites (1)

Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal

Montreal, Quebec, H1T2M4, Canada

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Philippe Richebé, MD, PhD

  CIUSSS Est de l'ile de Montreal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe Richebé, MD PhD

CONTACT

514-743-6558; philippe.richebe@umontreal.ca

Nadia Godin, RN

CONTACT

514-525-3400; ngodin.hmr@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The drug administered intraoperatively (intravenous lidocaine or intravenous placebo) will be blinded to patient, anesthesiologist, research nurse for the entire duration of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research in Anesthesiology, MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: April 29, 2019
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)