Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02067806 |
| Other study ID # |
CHL1/01-2012/M |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 2013 |
| Est. completion date |
October 2016 |
Study information
| Verified date |
June 2021 |
| Source |
Sintetica SA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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.
