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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
Sponsor:
Collaborator:
Sintesi Research Srl
Information provided by (Responsible Party):
Sintetica SA

Brief 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).

Condition or disease Intervention/treatment
Neurological Complication, in Particular TNS or CES Drug: Spinal administration of chloroprocaine

Detailed Description:

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 394 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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).
Criteria

Inclusion Criteria:

  • Male/female adult patients
  • Ability to comprehend the full nature and purpose of the study
  • Ability to co-operate with the Investigator and to comply with the requirements of the entire study
  • Signed written informed consent of the patients prior to inclusion in the observational study. The signature has to be done before the elective surgery.
  • Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.

Exclusion Criteria:

  • Hypersensitivity to the active substance, medicinal products of the PABA (para-aminobenzoic acid) ester group, other ester-type local anaesthetics or to any of the excipients (Hydrochloric acid 1N for pH adjustment, Sodium chloride, Water for injection)
  • General and specific contra-indications to spinal anaesthesia regardless of the local anaesthetic used, should be taken into account (e.g. decompensated cardiac insufficiency, hypovolemic shock….)
  • Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area)
  • Serious problems with cardiac conduction,
  • Severe anaemia,
  • It is also necessary to take into consideration general and specific contraindications for the technique of spinal anaesthesia = intrathecal anaesthesia

Information from the National Library of Medicine

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


Locations
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Belgium
Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef
Malle, Belgium, 2390
Sponsors and Collaborators
Sintetica SA
Sintesi Research Srl
Investigators
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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

Additional Information:

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Responsible Party: Sintetica SA
ClinicalTrials.gov Identifier: NCT02067806     History of Changes
Other Study ID Numbers: CHL1/01-2012/M
First Posted: February 20, 2014    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Keywords provided by Sintetica SA:
PASS
TNS
CES
CHLOROPROCAINE
Additional relevant MeSH terms:
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Chloroprocaine
Procaine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents