Evidence map›Paper›PMID 27404223›Full record

Trial reportAnesthesiology2016

Effect of Intralipid® on the Dose of Ropivacaine or Levobupivacaine Tolerated by Volunteers: A Clinical and Pharmacokinetic Study.

Pauline Dureau, Beny Charbit, Nathalie Nicolas, Dan Benhamou, Jean-Xavier Mazoit

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Anesthesiology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01602250 (Prevention of Systemic Toxicity Induced by Levobupivacaine and Ropivacaine by Intralipid®), which is not on this map. Cited by 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
9.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01602250 phase2completednot on this map

Prevention of Systemic Toxicity Induced by Levobupivacaine and Ropivacaine by Intralipid®

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2011 to 2013Enrolled16ConditionsToxicity, Adverse EffectsArmsplacebo, Intralipid®
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

  1. Systematic Review and Meta-Analysis of Lipid Emulsion for Non-Local Anesthetic Poisoning.Journal of medical toxicology : official journal of the American College of Medical Toxicology · 2026
    Pooled it
  2. Article
  3. Local anesthetic dosing for fascial plane blocks to avoid systemic toxicity: a narrative review.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 2025
    Review
  4. Article
  5. Article
  6. Review
  7. Lipid emulsion for xenobiotic overdose: PRO.British journal of clinical pharmacology · 2023
    Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Local Anesthesia in Interventional Radiology.Seminars in interventional radiology · 2022
    Review
  14. Article
  15. Article
  16. Review
  17. Update on Local Anesthetic Toxicity, Prevention and Treatment During Regional Anesthesia in Infants and Children.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 5 institutions in 1 country.

Pauline DureauFrom the Département d'Anesthésie-Réanimation, Hôpitaux Universitaires Paris-Sud AP-HP, Paris, France (D.B., J.-X.M.); Faculté de Médecine, Laboratoire d'Anesthésie, INSERM UMR 788, Université Paris-Sud, Bicêtre Cedex, Paris, France (D.B., J.-X.M.); and Centre d'Investigation Clinique Paris-Est Hôpital de la Pitié-Salpêtrière AP-HP, Paris, France (P.D., B.C., N.N.). Current position: Département d'Anesthésie-Réanimation, Centre Hospitalier Universitaire, Reims, France (B.C.).
Beny Charbit
Nathalie Nicolas
Dan Benhamou
Jean-Xavier Mazoit
Hôpitaux Universitaires Paris-Ouest · FRInserm · FRPitié-Salpêtrière Hospital · FRSorbonne Université · FRUniversité Paris-Sud · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRapid intravenous administration of lipid emulsion has become the standard treatment of severe local anesthetic systemic toxicity. This experiment in volunteers aimed at determining the effect of Intralipid® administration on the time to neurologic symptoms.

methodsRopivacaine or levobupivacaine was infused intravenously in 16 volunteers (8 mg/min up to 120 mg) with 120 ml Intralipid® 20% (Fresenius, Paris France) or placebo infused at T + 2 min). Each subject received all four treatments in a crossover manner. The infusion was stopped after the intended dose had been administered or on occurrence of incipient neurologic signs of toxicity. The primary outcome was time-to-event. In addition, blood ropivacaine and levobupivacaine concentrations were measured.

resultsThe dose infused was not different whether volunteers received placebo (81.7 ± 22.3 vs. 80.8 ± 31.7 mg, ropivacaine vs. levobupivacaine) or Intralipid® (75.7 ± 29.1 vs. 69.4 ± 26.2 mg, ropivacaine vs. levobupivacaine), P = 0.755, Intralipid® versus placebo groups. Plasma concentrations were best modeled with an additional volume of distribution associated with Intralipid®. Simulations suggested that decreased peak concentrations would be seen if Intralipid® was given during a period of increasing concentrations after extravascular administration.

conclusionsAt modestly toxic doses of ropivacaine or levobupivacaine, we were unable to find any effect of the infusion of Intralipid® on the time to early signs of neurologic toxicity in volunteers. Peak concentration was decreased by 26 to 30% in the subjects receiving Intralipid®. Simulations showed that Intralipid® might prevent the rapid increase of local anesthetic concentration after extravascular administration.

Indexed as

AmidesAnesthetics, LocalBlood PressureBupivacaineCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodElectrocardiographyEmulsionsFemaleHumansInfusions, IntravenousLevobupivacaineMaleOximetryPhospholipidsAmidesAnesthetics, LocalBupivacaineEmulsionsLevobupivacainePhospholipidsRopivacaineSoybean Oilsoybean oil, phospholipid emulsion

Identifiers

PMID27404223
OpenAlexW2474564943

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.