Local Anaesthetics Toxicity and Intralipid®
TOXALIP
Prevention of Systemic Toxicity Induced by Levobupivacaine and Ropivacaine by Intralipid®
1 other identifier
interventional
16
1 country
1
Brief Summary
The systemic toxicity of local anaesthetics may be treated using lipid emulsions ("lipid rescue"). However, there is no evidence-based proof of the efficacy of the treatment. The aim of the intended protocol is to study the effect of the emulsion Intralipid® on the toxicity prodromes in volunteers receiving either levobupivacaine or ropivacaine. After a sensitization session with lidocaine, subjects will receive in a double blind, crossover manner an i.v. infusion of levobupivacaine or ropivacaine followed by a rapid infusion of Intralipid®. The primary outcome will be the time of appearance of early neurologic signs of toxicity. In addition, the EEG and ECG will be monitored and blood sampling will be performed in order to evaluate the changes in pharmacokinetics induced by the emulsion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 23, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedDecember 21, 2016
November 1, 2012
2.6 years
February 23, 2012
December 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of drug infusion
less than 15 minutes
Secondary Outcomes (3)
EEG : electroencephalogram
< 15 minutes
ECG : electrocardiogram
< 15 minutes
pharmacokinetics of local anesthetics (Area under the plasma concentration versus time curve (AUC))
8 h
Study Arms (4)
levobupivacaine placebo
PLACEBO COMPARATORlevobupivacaine placebo
levobupivacaine Intralipid®
EXPERIMENTALlevobupivacaine Intralipid®
ropivacaine Intralipid®
EXPERIMENTALropivacaine Intralipid®
ropivacaine placebo
PLACEBO COMPARATORropivacaine placebo
Interventions
Levobupivacaine 8 mg/min ropivacaine 8 mg/min
Levobupivacaine 8 mg/min ropivacaine 8 mg/min Intralipid® 120 ml in one min
Eligibility Criteria
You may qualify if:
- Volunteers ASA1
You may not qualify if:
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CIC plurithématique Paris-Est (CIC-9304)
Paris, 75013, France
Related Publications (1)
Dureau P, Charbit B, Nicolas N, Benhamou D, Mazoit JX. Effect of Intralipid(R) on the Dose of Ropivacaine or Levobupivacaine Tolerated by Volunteers: A Clinical and Pharmacokinetic Study. Anesthesiology. 2016 Sep;125(3):474-83. doi: 10.1097/ALN.0000000000001230.
PMID: 27404223RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dan Benhamou
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2012
First Posted
May 18, 2012
Study Start
January 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
December 21, 2016
Record last verified: 2012-11