Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
|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
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|