Observational Study on 2-chloroprocaine Hydrochloride 1%

NCT02067806 | Completed Results

• 1 other identifier: CHL1/01-2012/M
• Study Type: observational
• Target: 394
• Locations: 1 country
• Sites: 1

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).

Conditions

Neurological Complication, in Particular TNS or CES

Keywords

PASS; TNS; CES; CHLOROPROCAINE

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

2-chloroprocaine hydrochloride, 1% DRUG

Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.

Also known as: Ampres 1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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
• Spinal anaesthesia in adults where the planned surgical procedure should not exceed 40 minutes.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sintetica SA: lead
• Sintesi Research Srl: collaborator

Study Sites (1)

Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef

Malle, 2390, Belgium

Location

MeSH Terms

Conditions

Schmid-Fraccaro syndrome

Results Point of Contact

• Title: Dr.Elisabetta Donati, Corporate Director Scientific Affairs
• Organization: Sintetica SA

edonati@sintetica.com

+41.91.640.42.50

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 20, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 29, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Locations

BE (1)