NCT03642301|Completed
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Sponsor study identifier
observational
10
1 country
1
Study Start
January 10, 2019
Actual (reported)Primary Completion
March 27, 2019
Actual (reported)Study Completion
March 27, 2019
Actual (reported)The prilocaine is a very common local anesthetic that has the disadvantage of being metabolized to o-toluidine, a human carcinogen. Hyperbaric 2% prilocaine (HP), recently developped, is increasingly used for spinal anesthesia in ambulatory surgery. But the formation of carcinogenic metabolites induced by the hyperbaric prilocaine is not yet known. The aim of this study is to investigate whether the intrathecal administration of 50 mg hyperbaric prilocaine induces also the formation of carcinogenic complexes such as urinary o-toluidine and hemoglobin adducts from o-toluidine in blood.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 27, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2018
Actual (reported)August 22, 2018
Actual (reported)January 10, 2019
Actual (reported)March 27, 2019
Actual (reported)March 27, 2019
Actual (reported)Hemoglobin adducts from o-toluidine in blood
Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission)
Time 0 (before surgery)
Hemoglobin adducts from o-toluidine in blood
Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection
Time 24 hours after intrathecal prilocaine injection
Urinary o-toluidine
Urinary o-toluidine is measured before surgery (at admission)
Time 0 (before surgery)
Urinary o-toluidine
Urinary o-toluidine is measured at 6 hours after intrathecal prilocaine injection
Time 6 hours after intrathecal prilocaine injection
Urinary o-toluidine
Urinary o-toluidine is measured at 12 hours after intrathecal prilocaine injection
Time 12 hours after intrathecal prilocaine injection
Patient scheduled for an ambulatory surgery
Braine-l'Alleud Hospital
Braine-l'Alleud, 1420, Belgium
Gaber K, Harreus UA, Matthias C, Kleinsasser NH, Richter E. Hemoglobin adducts of the human bladder carcinogen o-toluidine after treatment with the local anesthetic prilocaine. Toxicology. 2007 Jan 5;229(1-2):157-64. doi: 10.1016/j.tox.2006.10.012. Epub 2006 Oct 29.
Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7.
Whole blood (2 samples) and Urine (4 samples)
Emmanuel Guntz, MD
Université Libre de Bruxelles (ULB), Braine-l'Alleud Hospital
Panayota Kapessidou, MD,PhD
University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
10 participants (actual enrollment reported by the registry).
First Submitted
July 24, 2018
First Posted
August 22, 2018
Study Start
January 10, 2019
Actual (reported)Duration and Depth of Anesthesia Induced by a Bolus of Etomidate
Urinary o-toluidine
Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection
Time 24 hours after intrathecal prilocaine injection
Contact the study team to confirm eligibility.
Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.
Gebhardt V, Herold A, Weiss C, Samakas A, Schmittner MD. Dosage finding for low-dose spinal anaesthesia using hyperbaric prilocaine in patients undergoing perianal outpatient surgery. Acta Anaesthesiol Scand. 2013 Feb;57(2):249-56. doi: 10.1111/aas.12031. Epub 2012 Nov 30.
Bohm F, Schmid D, Denzinger S, Wieland WF, Richter E. DNA adducts of ortho-toluidine in human bladder. Biomarkers. 2011 Mar;16(2):120-8. doi: 10.3109/1354750X.2010.534556. Epub 2010 Nov 30.
Guntz E, Carini A, Koslitz S, Bruning T, Kapessidou P, Weiss T. Quantification of systemic o-toluidine after intrathecal administration of hyperbaric prilocaine in humans: a prospective cohort study. Arch Toxicol. 2021 Mar;95(3):925-934. doi: 10.1007/s00204-021-02973-w. Epub 2021 Jan 21.
Primary Completion
March 27, 2019
Actual (reported)Study Completion
March 27, 2019
Actual (reported)Last Updated
May 22, 2019
Record last verified: 2019-05
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Source: ClinicalTrials.gov.
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