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
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain||Drug: Lidocaine, Drug: Ketamine Drug: association ketamine-lidocaine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Active Comparator: Lidocaine
Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
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
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%
The control group (C) received an equal volume of saline 0.9 % during 48 h.
- Cumulative morphine consumption [ Time Frame: 48 hours ]Cumulative morphine consumption over 48 hours postoperatively
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01439399
|University Hospital Center and University|
|Lausanne, Vaud, Switzerland, CH-1011|
|Study Director:||Christian Kern||University of Lausanne Hospitals|