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Observational Prospective Study on 2-chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia (PASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date February 7, 2014
First Posted Date February 20, 2014
Last Update Posted Date January 20, 2017
Study Start Date November 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 17, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02067806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observational Prospective Study on 2-chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia
Official Title OBSERVATIONAL PROSPECTIVE STUDY ON 2-CHLOROPROCAINE HYDROCHLORIDE 1% SAFETY IN INTRATHECAL ANAESTHESIA
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).
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 7 Days
Biospecimen Not Provided
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).
Condition Neurological Complication, in Particular TNS or CES
Intervention Drug: Spinal administration of chloroprocaine
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 19, 2017)
394
Original Estimated Enrollment
 (submitted: February 17, 2014)
380
Actual Study Completion Date October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02067806
Other Study ID Numbers CHL1/01-2012/M
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sintetica SA
Study Sponsor Sintetica SA
Collaborators Sintesi Research Srl
Investigators
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
PRS Account Sintetica SA
Verification Date January 2017