Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Lidocaine,; Drug: Ketamine; Drug: association ketamine-lidocaine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, CH-1011
      • University Hospital Center and University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours	Drug: Lidocaine,; 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.
Active Comparator: Ketamine; Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours	Drug: Ketamine; 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.
Active Comparator: Ketamine-Lidocaine; Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.	Drug: association ketamine-lidocaine; 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 Comparator: Saline 0,9%; Control group	Drug: Placebo; The control group (C) received an equal volume of saline 0.9 % during 48 h.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative morphine consumption	Cumulative morphine consumption over 48 hours postoperatively	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores at rest and movement	48 hours
Mechanical hyperalgesia	Mechanical hyperalgesia using pressure algometry	48 hours
Occurrence of side effects	Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares	48 hours

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Study Director: Christian Kern, University of Lausanne Hospitals

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 20, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (Estimate): September 23, 2011

Study Record Updates

• Last Update Posted (Estimate): September 23, 2011
• Last Update Submitted That Met QC Criteria: September 21, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: postoperative pain; postoperative care; morphine consumption; intravenous lidocaine; intravenous ketamine
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Lidocaine
• Other Study ID Numbers: KL-48h; 179/05 (Other Identifier: Cantonal Ethics Committee of Research on human)