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Intravenous Lidocaine for Laparoscopic Cholecystectomy

McGill University logo

McGill University

Status

Completed

Conditions

Postoperative Pain
Opioid Consumption

Treatments

Drug: Lidocaine
Drug: Fentanyl

Study type

Interventional

Funder types

Other

Identifiers

NCT01062906
GEN#08-021

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups, including a placebo group

Control
Placebo Comparator group
Description:
The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery.
Treatment:
Drug: Fentanyl
Lidocaine
Active Comparator group
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
Treatment:
Drug: Lidocaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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