Observational Prospective Study on 2-chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia (PASS)
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|ClinicalTrials.gov Identifier: NCT02067806|
Recruitment Status : Completed
First Posted : February 20, 2014
Last Update Posted : January 20, 2017
|Condition or disease||Intervention/treatment|
|Neurological Complication, in Particular TNS or CES||Drug: Spinal administration of chloroprocaine|
Primary endpoint :Incidence of neurological complications (Transient and Permanent complications; e.g. transient neurological symptoms, arachnoiditis, cauda equina syndrome).Two follow-up questionnaires are foreseen, at 24 h and 7 days after time of spinal injection (Tsp), to gather all possible neurological complications, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).Patients scheduled for elective surgery will be informed about the aims, procedures and possible risks of the study and will be asked to sign the informed consent form for the inclusion in the trial, from day -14 to day of surgery (visit 1, Day 0).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). The mandatory follow-ups of the study are at 24 h and 7 days (-1/+2) after anaesthesia. In case of signs of neurological complications, the patient has to undergo to a medical visit at the hospital by the relevant specialists (anaesthetist, surgeon, neurologist). In order to characterise the occurred adverse event, a complete analysis evaluation has to be conducted, as CT, MRI, Electromyography, etc. following the indication of the specialists. In case of persistent neuropathy the patient needs to be accurately followed according to the internal hospital procedure. In the meantime, a full screening of the patient's clinical history together with a detailed analysis of the relevant variables, potentially related to the adverse event, have to be carried out.
Therefore, the physician will take all appropriate measures to ensure the safety of the patients, notably he/she should follow up the outcome of any Adverse Events (clinical signs, laboratory values or other, etc.) until the return to normal or consolidation of the patient's condition. In case of any Serious Adverse Event, the patient has to be followed up until clinical recovery is complete and laboratory results have returned to normal, or until progression has been stabilized. The follow-up will continue after the patient has left the study.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||394 participants|
|Target Follow-Up Duration:||7 Days|
|Official Title:||OBSERVATIONAL PROSPECTIVE STUDY ON 2-CHLOROPROCAINE HYDROCHLORIDE 1% SAFETY IN INTRATHECAL ANAESTHESIA|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
- Number of participants with AE,with particular attention to Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES) after intrathecal anaesthesia with 2-chloroprocaine hydrochloride [ Time Frame: Evaluate the relationship between spinal block with 1% solution of 2-chloroprocaine hydrochloride and the onset of all possible neurological AE,with particular attention TNS and CES at 24h and 7(-1/+2) days after surgery ]
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).
Two follow-up questionnaires are foreseen, at 24 h and 7 days after time of spinal injection (Tsp),to gather all possible neurological complications,with particular attention to TNS and CES.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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02067806
|Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef|
|Malle, Belgium, 2390|
|Principal Investigator:||Guido Fanelli, MD||Azienda Ospedaliera di Parma - Università di Parma -Dipartimento di Anestesia, Rianimazione e Terapia Antalgica - Italy|
|Principal Investigator:||Capdevila Xavier, MD||Head of the Department of Anesthesiology and Critical Care Medicine of Lapeyronie University Hospital and Montpellier University, France|
|Principal Investigator:||Stefano Bonarelli, MD||Rizzoli Hospital, Bologna - Italy|
|Principal Investigator:||John Van Delft, MD||Head of The Department of Anesthesiology and Critical Care Medicine, Hospital Sint Jozeph,Malle-Belgium|
|Principal Investigator:||Holger Sauer, MD||Klinik für Anästhesie, Intensivmedizin und Schmerztherapie|
|Principal Investigator:||Martin Bauer, MD||Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil|
|Principal Investigator:||Laurent Delaunay, MD||Clinique générale d'Annency - La consultation d'Anesthésie|