Observational Study on 2-chloroprocaine Hydrochloride 1%

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sintetica SA
• Collaborator: Sintesi Research Srl
• Treatments: Chloroprocaine; Procaine

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