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Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joray Florence, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01439399
First received: September 20, 2011
Last updated: September 21, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention
Postoperative Pain
 Drug: Lidocaine,
Drug: Ketamine
Drug: association ketamine-lidocaine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • Cumulative morphine consumption [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Cumulative morphine consumption over 48 hours postoperatively


Secondary Outcome Measures:
  • Pain scores [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Pain scores at rest and movement

  • Mechanical hyperalgesia [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Mechanical hyperalgesia using pressure algometry

  • Occurrence of side effects [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares


Enrollment: 52
Study Start Date: December 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01439399

Locations
Switzerland
University Hospital Center and University
Lausanne, Vaud, Switzerland, CH-1011
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
Study Director: Christian Kern University of Lausanne Hospitals
  More Information

No publications provided

Responsible Party: Joray Florence, Chief Resident, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01439399     History of Changes
Other Study ID Numbers: KL-48h, 179/05
Study First Received: September 20, 2011
Last Updated: September 21, 2011
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
postoperative pain
postoperative care
intravenous lidocaine
intravenous ketamine
morphine consumption

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Ketamine
Lidocaine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013