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Observational Study on 2-chloroprocaine Hydrochloride 1%

NCT02067806 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 394

Last updated 2021-06-29

Study results available
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Summary

The present study aims to evaluate the relationship between spinal block with 1% solution of 2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).

Conditions

  • Neurological Complication, in Particular TNS or CES

Interventions

DRUG

2-chloroprocaine hydrochloride, 1%

Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.

Sponsors & Collaborators

  • Sintesi Research Srl

    collaborator INDUSTRY

  • Sintetica SA

    lead INDUSTRY

Principal Investigators

  • Guido Fanelli, MD · Azienda Ospedaliera di Parma Dipartimento di Anestesia, Rianimazione e Terapia Antalgica - Italy

  • Capdevila Xavier, MD · Head of the Department of Anesthesiology and Critical Care Medicine of Lapeyronie, France

  • Stefano Bonarelli, MD · Rizzoli Hospital, Bologna - Italy

  • John Van Delft, MD · Department of Anesthesiology and Critical Care Medicine, Belgium

  • Holger Sauer, MD · Klinik für Anästhesie, Intensivmedizin und Schmerztherapie

  • Martin Bauer, MD · Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches

  • Laurent Delaunay, MD · Clinique générale d'Annency - La consultation d'Anesthésie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02067806 on ClinicalTrials.gov