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

Condition(s) targeted: Neurological Complication, in Particular TNS or CES

Intervention: Spinal administration of chloroprocaine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Sintetica SA

Official(s) and/or principal investigator(s):
Guido Fanelli, MD, Principal Investigator, Affiliation: Azienda Ospedaliera di Parma - Università di Parma -Dipartimento di Anestesia, Rianimazione e Terapia Antalgica - Italy
Capdevila Xavier, MD, Principal Investigator, Affiliation: Head of the Department of Anesthesiology and Critical Care Medicine of Lapeyronie University Hospital and Montpellier University, France
Stefano Bonarelli, MD, Principal Investigator, Affiliation: Rizzoli Hospital, Bologna - Italy
John Van Delft, MD, Principal Investigator, Affiliation: Head of The Department of Anesthesiology and Critical Care Medicine, Hospital Sint Jozeph,Malle-Belgium
Holger Sauer, MD, Principal Investigator, Affiliation: Klinik für Anästhesie, Intensivmedizin und Schmerztherapie
Martin Bauer, MD, Principal Investigator, Affiliation: Klinik für Anästhesiologie, Intensiv-, Palliativ- und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil

Overall contact:
Elisabetta Donati, Phone: +41(0)916404250, Ext: 0041, Email: edonati@sintetica.com

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).

Official title: OBSERVATIONAL PROSPECTIVE STUDY ON 2-CHLOROPROCAINE HYDROCHLORIDE 1% SAFETY IN INTRATHECAL ANAESTHESIA

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of participants with AE,with particular attention to Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES) after intrathecal anaesthesia with 2-chloroprocaine hydrochloride

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.

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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

Elisabetta Donati, Phone: +41(0)916404250, Ext: 0041, Email: edonati@sintetica.com

Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef, Malle 2390, Belgium; Recruiting
John van Delft, MD, Phone: +32 3 3122913, Email: johnvandelft@telenet.be

Starting date: November 2013
Last updated: May 18, 2015