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Intravenous Lidocaine for Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain, Opioid Consumption

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lidocaine

Fentanyl

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring intravenous lidocaine, postoperative pain, laparoscopic surgery, opioids, opioids side-effects

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

patients undergoing laparoscopic cholecystectomy

Exclusion Criteria:

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.

Sites / Locations

McGill University Health Centre, Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control

Lidocaine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fentanyl consumption (measured as fentanyl equivalents -mcg)

Secondary Outcome Measures

Pain, Static and Dynamic

Opioids side-effects

Full Information

NCT ID

NCT01062906

First Posted

February 3, 2010

Last Updated

January 12, 2011

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

1. Study Identification

Unique Protocol Identification Number

NCT01062906

Brief Title

Intravenous Lidocaine for Laparoscopic Cholecystectomy

Official Title

The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Opioid Consumption

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Lidocaine

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

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)

Primary Outcome Measure Information:

Title

Fentanyl consumption (measured as fentanyl equivalents -mcg)

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain, Static and Dynamic

Time Frame

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

Title

Opioids side-effects

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: patients undergoing laparoscopic cholecystectomy Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco Carli, MD, professor

Organizational Affiliation

McGill University Healt Centre, Department of Anesthesia

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre, Montreal General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G1A4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19138915

Citation

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.

Results Reference

background

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Intravenous Lidocaine for Laparoscopic Cholecystectomy

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