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Completed

NCT Number: NCT01439399

Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.

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Key information

Conditions

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

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Center and University

Lausanne, Canton of Vaud, CH-1011, Switzerland

About this study

Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • abdominal surgery by laparotomy

Exclusion criteria

  • laparoscopy
  • history of chronic pain
  • opioid self-administration
  • psychiatric disorders
  • difficulties with communication
  • renal or hepatic dysfunction
  • ASA physical status > 3

Treatment and study plan

Lidocaine,

Drug

Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.

ketamine

Drug

Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.

association ketamine-lidocaine

Drug

Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.

Placebo

Drug

The control group (C) received an equal volume of saline 0.9 % during 48 h.

Primary outcomes

  1. Cumulative morphine consumption

    Time frame: 48 hours

    Cumulative morphine consumption over 48 hours postoperatively

Secondary outcomes

  1. Pain scores

    Time frame: 48 hours

    Pain scores at rest and movement

  2. Mechanical hyperalgesia

    Time frame: 48 hours

    Mechanical hyperalgesia using pressure algometry

  3. Occurrence of side effects

    Time frame: 48 hours

    Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Registry information

Official study title

Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Sep 23, 2011
Registry last updated
Sep 23, 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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