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AnesthesiaNCT03642301

Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal Hyperbaric Prilocaine.

An observational study of Anesthesia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Anesthesia
How many people
10 participants
Where
1 siteBelgium
Study dates
10 Jan 2019to 27 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patient scheduled for an ambulatory surgery

Who may be able to join

  • Age : > 18 years and < 80years
  • American Society of Anesthesiology (ASA) score : I-II
  • Height between 160cm and 180cm

Who cannot join

  • Cardiac Disease (Aortic stenosis, heart failure...)
  • coagulation disorder (International Normalized Ratio (INR) > 1.3; platelets <80 000/mm³)
  • Allergic to local anesthetics
  • Smoker

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • Braine-l'Alleud Hospital

    Braine-l'Alleud, 1420

Other trials in Belgium

About this study

Official title: Dosing of Carcinogenic Complexes Such as Urinary O-toluidine and Hemoglobin Adducts From O-toluidine in Blood After Intrathecal Administration of 50 mg Hyperbaric Prilocaine

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.

Conditions
Anesthesia
Keywords
Hemoglobin adducts from o-toluidine in blood, Urinary o-toluidine, Intrathecal anesthesia, Hyperbaric prilocaine, Ambulatory surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hemoglobin adducts from o-toluidine in blood

    Hemoglobin adducts from o-toluidine in blood is measured before surgery (at admission)

    Measured: Time 0 (before surgery)

  2. Hemoglobin adducts from o-toluidine in blood

    Hemoglobin adducts from o-toluidine in blood is measured at 24 hours after intrathecal prilocaine injection

    Measured: Time 24 hours after intrathecal prilocaine injection

  3. Urinary o-toluidine

    Urinary o-toluidine is measured before surgery (at admission)

    Measured: Time 0 (before surgery)

  4. Urinary o-toluidine

    Urinary o-toluidine is measured at 6 hours after intrathecal prilocaine injection

    Measured: Time 6 hours after intrathecal prilocaine injection

  5. Urinary o-toluidine

    Urinary o-toluidine is measured at 12 hours after intrathecal prilocaine injection

    Measured: Time 12 hours after intrathecal prilocaine injection

  6. Urinary o-toluidine

    Urinary o-toluidine is measured at 24 hours after intrathecal prilocaine injection

    Measured: Time 24 hours after intrathecal prilocaine injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start10 Jan 2019
  3. Primary completion27 Mar 2019
  4. Study completion27 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642301
Sponsor's protocol ID
B076201836443
Status last verified
May 2019
First submitted
24 Jul 2018
Last updated
22 May 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17129655

  • 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.

    PubMed 20529983

  • 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.

    PubMed 24906303

  • 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.

    PubMed 23199005

  • 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.

    PubMed 21117897

  • 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.

    PubMed 33475793

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemoglobin adducts from o-toluidine in blood (time frame: Time 0 (before surgery)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642301, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.

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