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Completed

NCT Number: NCT01062906

Intravenous Lidocaine for Laparoscopic Cholecystectomy

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre, Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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)

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Opioids side-effects

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 4, 2010
Registry last updated
Jan 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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