Observational Prospective Study on 2-Chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33371
• EU PAS number:
  EUPAS16398
• Study ID:
  33371
• Official title and acronym:
  Observational Prospective Study on 2-Chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France

  Germany

  Italy
• Study description:
  The present study aims to evaluated in 380 patients 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).This is a prospective, observational, multicenter study involving 7 different centers distributed in 4 European countries: Italy, France, Belgium and Germany. This observational study is planned to collect data on patients undergoing surgery under intrathecal anesthesia with chloroprocaine hydrochloride, primarily to assess the occurrence of all possible neurological adverse events (with particular attention to TNS and CES).Two follow-up questionnaires are foreseen, at 24 h and 7 days after time of spinal injection (Tsp), to gather all possible neurological complications. About 24 h after surgery (indicated as Tsp), Investigator or a deputy will question patients about neurological symptoms, in particular TNS/CES, and pain not associated to the operation area on the basis of the two follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other AEs will also be assessed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Azienda Ospedaliera di Parma - Università di Parma -Dipartimento di Anestesia, Rianimazione e Terapia Antalgica

Department of Anesthesiology and Critical Care Medicine of Lapeyronie University Hospital and Montpellier University Montpellier, France, Rizzoli Hospital Bologna, Italy, Department of Anesthesiology and Critical Care Medicine, Hospital Sint Jozeph Malle, Belgium, Klinik für Anästhesie, Intensivmedizin und Schmerztherapie, Klinikum Westfalen Gmbh Lünen, Germany, Department of Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil Bochum, Germany, Clinique générale d'Annency - La consultation d'Anesthésie Annecy, France

Study timelines

Date when funding contract was signed

Actual: 22/02/2013

Study start date

Actual: 26/11/2013

Date of final study report

Planned: 27/05/2017

Actual: 26/05/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sintetica SA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

ClinicalTrials.gov Identifier:NCT02067806