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NCT Number: NCT03642301

Dosing of Carcinogenic Complexes After Anesthesia With Intrathecal 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.

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Key information

Conditions

Anesthesia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Braine-l'Alleud Hospital

Braine-l'Alleud, 1420, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Hemoglobin adducts from o-toluidine in blood

    Time frame: Time 0 (before surgery)

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

  2. Hemoglobin adducts from o-toluidine in blood

    Time frame: Time 24 hours after intrathecal prilocaine injection

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

  3. Urinary o-toluidine

    Time frame: Time 0 (before surgery)

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

  4. Urinary o-toluidine

    Time frame: Time 6 hours after intrathecal prilocaine injection

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

  5. Urinary o-toluidine

    Time frame: Time 12 hours after intrathecal prilocaine injection

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

  6. Urinary o-toluidine

    Time frame: Time 24 hours after intrathecal prilocaine injection

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Saint Pierre

Other

Collaborators

  • Hôpital de Braine-l'Alleud
  • Ruhr University of Bochum

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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