Clinical trial

Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study

Name

2017-1066

Description

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.

Trial arms

Trial start

2019-04-29

Estimated PCD

2024-12-01

Trial end

2025-06-01

Status

Recruiting

Phase

Early phase I

Treatment

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).

Arms:

intravenous lidocaine (IVL)

Placebo

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

Arms:

Placebo

Size

Primary endpoint

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.

Intra-operative, 5 hours

Eligibility 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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The drug administered intraoperatively (intravenous lidocaine or intravenous placebo) will be blinded to patient, anesthesiologist, research nurse for the entire duration of the study.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-10-18

1 organization

1 product

1 indication

Organization

CIUSSS de l'Est de l'Île de Montréal

Product

Lidocaine

Indication

Intravenous Lidocaine and Immunity