Intravenous Lidocaine for Laparoscopic Cholecystectomy

NCT01062906 | Completed DMC

• 1 other identifier: GEN#08-021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%. The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.

Conditions

Postoperative Pain; Opioid Consumption

Keywords

intravenous lidocaine; postoperative pain; laparoscopic surgery; opioids; opioids side-effects

Outcome Measures

Primary Outcomes (1)

• Fentanyl consumption (measured as fentanyl equivalents -mcg)

  postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery

Secondary Outcomes (2)

• Pain, Static and Dynamic

  On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery

• Opioids side-effects

  On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.

Drug: Fentanyl

Lidocaine

ACTIVE COMPARATOR

The Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery

Drug: Lidocaine

Interventions

Lidocaine DRUG

1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)

Lidocaine

Fentanyl DRUG

Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing laparoscopic cholecystectomy

You may not qualify if:

• age \<18 yr or \> 85 yr,
• ASA physical status 3 and greater, history of hepatic failure (Child \& Pug A-C),
• renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
• Adams-Stoke syndrome,
• severe degrees of sinoatrial, atrioventricular or intraventricular block,
• organ transplant,
• diabetes mellitus type 1 and 2,
• morbid obesity (BMI \> 40),
• chronic use of opioids and beta-blockers,
• known seizures,
• severe mental impairment,
• allergy to local anesthetics and to all the medications used in the study, or
• inability to understand pain assessment.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre, Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

Related Publications (1)

• Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.

  PMID: 19138915 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Franco Carli, MD, professor

  McGill University Healt Centre, Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 4, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: January 13, 2011

Record last verified: 2010-02

Locations

CA (1)