Observational Study on 2-chloroprocaine Hydrochloride 1% (PASS)

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

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).

Study Overview

• Status: Completed
• Conditions: Neurological Complication, in Particular TNS or CES
• Intervention / Treatment: Drug: 2-chloroprocaine hydrochloride, 1%

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
• Enrollment (Actual): 394

Contacts and Locations

Study Locations

• Belgium
  • Malle, Belgium, 2390
    • Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES).	assessed at 24h and 7(-1/+2) days after surgery, total reported
Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours	the follow-up questionnaires are foreseen, at 24 h after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 24 h after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.	24 hours
Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days	the follow-up questionnaires are foreseen, at 7 days after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 7 days after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.	7 days

Collaborators and Investigators

• Sponsor: Sintetica SA
• Collaborators: Sintesi Research Srl
• Investigators: Principal Investigator: Guido Fanelli, MD, Azienda Ospedaliera 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, France; Principal Investigator: Stefano Bonarelli, MD, Rizzoli Hospital, Bologna - Italy; Principal Investigator: John Van Delft, MD, Department of Anesthesiology and Critical Care Medicine, 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; Principal Investigator: Laurent Delaunay, MD, Clinique générale d'Annency - La consultation d'Anesthésie

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 17, 2014
• First Posted (Estimate): February 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 29, 2021
• Last Update Submitted That Met QC Criteria: June 8, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: PASS; TNS; CES; CHLOROPROCAINE
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Chloroprocaine
• Other Study ID Numbers: CHL1/01-2012/M