Clinical trial NCT02067806: Observational Study on 2-chloroprocaine Hydrochloride 1%
Official title: Observational Prospective Study on 2-chloroprocaine Hydrochloride 1% Safety in Intrathecal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurological Complication, in Particular TNS or CES
Keywords: PASS
TNS
CES
CHLOROPROCAINE
Lead sponsor: Sintetica SA
Sponsor class: INDUSTRY
Collaborators: name: Sintesi Research Srl
First posted: 2014-02-20
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: assessed at 24h and 7(-1/+2) days after surgery, total reported
measure: Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours
timeFrame: 24 hours
measure: Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malle
country: Belgium
facility: Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef
Study officials:
affiliation: Azienda Ospedaliera di Parma Dipartimento di Anestesia, Rianimazione e Terapia Antalgica - Italy
name: Guido Fanelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of the Department of Anesthesiology and Critical Care Medicine of Lapeyronie, France
name: Capdevila Xavier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rizzoli Hospital, Bologna - Italy
name: Stefano Bonarelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Anesthesiology and Critical Care Medicine, Belgium
name: John Van Delft, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
name: Holger Sauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches
name: Martin Bauer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique générale d'Annency - La consultation d'Anesthésie
name: Laurent Delaunay, MD
role: PRINCIPAL_INVESTIGATOR
References: