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Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine

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ClinicalTrials.gov Identifier: NCT01439399
Recruitment Status : Completed
First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Sponsor:
Information provided by (Responsible Party):
Joray Florence, University of Lausanne Hospitals

Tracking Information
First Submitted Date  ICMJE September 20, 2011
First Posted Date  ICMJE September 23, 2011
Last Update Posted Date September 23, 2011
Study Start Date  ICMJE December 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
Cumulative morphine consumption [ Time Frame: 48 hours ]
Cumulative morphine consumption over 48 hours postoperatively
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2011)
  • Pain scores [ Time Frame: 48 hours ]
    Pain scores at rest and movement
  • Mechanical hyperalgesia [ Time Frame: 48 hours ]
    Mechanical hyperalgesia using pressure algometry
  • Occurrence of side effects [ Time Frame: 48 hours ]
    Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
Official Title  ICMJE Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study
Brief Summary The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
  • Drug: Placebo
    The control group (C) received an equal volume of saline 0.9 % during 48 h.
Study Arms  ICMJE
  • Active Comparator: Lidocaine
    Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
    Intervention: Drug: Lidocaine,
  • Active Comparator: Ketamine
    Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
    Intervention: Drug: Ketamine
  • Active Comparator: Ketamine-Lidocaine
    Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.
    Intervention: Drug: association ketamine-lidocaine
  • Placebo Comparator: Saline 0,9%
    Control group
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 21, 2011)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01439399
Other Study ID Numbers  ICMJE KL-48h
179/05 ( Other Identifier: Cantonal Ethics Committee of Research on human )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joray Florence, University of Lausanne Hospitals
Study Sponsor  ICMJE University of Lausanne Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christian Kern University of Lausanne Hospitals
PRS Account University of Lausanne Hospitals
Verification Date September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP