Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
2 other identifiers
interventional
52
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Dec 2005
Typical duration for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 20, 2011
CompletedFirst Posted
Study publicly available on registry
September 23, 2011
CompletedSeptember 23, 2011
September 1, 2011
1.6 years
September 20, 2011
September 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative morphine consumption
Cumulative morphine consumption over 48 hours postoperatively
48 hours
Secondary Outcomes (3)
Pain scores
48 hours
Mechanical hyperalgesia
48 hours
Occurrence of side effects
48 hours
Study Arms (4)
Lidocaine
ACTIVE COMPARATORIntravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
Ketamine
ACTIVE COMPARATORIntravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours
Ketamine-Lidocaine
ACTIVE COMPARATORIntravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours.
Saline 0,9%
PLACEBO COMPARATORControl group
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- abdominal surgery by laparotomy
You may not qualify if:
- laparoscopy
- history of chronic pain
- opioid self-administration
- psychiatric disorders
- difficulties with communication
- renal or hepatic dysfunction
- ASA physical status \> 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Center and University
Lausanne, Canton of Vaud, CH-1011, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian Kern
University of Lausanne Hospitals
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Resident
Study Record Dates
First Submitted
September 20, 2011
First Posted
September 23, 2011
Study Start
December 1, 2005
Primary Completion
July 1, 2007
Study Completion
July 1, 2007
Last Updated
September 23, 2011
Record last verified: 2011-09