NCT02067806

Observational Study on 2-chloroprocaine Hydrochloride 1%

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 394 (actual)
• Sponsor: Sintetica SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurological Complication, in Particular TNS or CES

Interventions

Type	Name	Description
DRUG	2-chloroprocaine hydrochloride, 1%	Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.

Timeline

• Start date: 2013-11-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-02-20
• Last updated: 2021-06-29
• Results posted: 2021-06-29

Locations

1 site across 1 country: Belgium