Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sintesi Research Srl | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Critical Care Medicine-Hospital AZ Sint Jozef | Malle | 2390 | Belgium |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Chloroprocaine 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Chloroprocaine 1% | intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Number | participants | assessed at 24h and 7(-1/+2) days after surgery, total reported |
|
|
7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Chloroprocaine 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bradycardia | Cardiac disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Elisabetta Donati, Corporate Director Scientific Affairs | Sintetica SA | +41.91.640.42.50 | edonati@sintetica.com |
Not provided
| ID | Term |
|---|---|
| C535918 | Schmid-Fraccaro syndrome |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
|
| Primary | 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. | Posted | Number | number of patients | 24 hours |
|
|
|
| Primary | 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. | Posted | Number | number of patients | 7 days |
|
|
|
| 0 |
| 393 |
| 0 |
| 393 |
| 37 |
| 393 |
| vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| drug effect incomplete | General disorders | Systematic Assessment |
|
| drug ineffective | General disorders | Systematic Assessment |
|
| injection site pain | General disorders | Systematic Assessment |
|
| anesthetic complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | Systematic Assessment |
|
| incision site pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural hypotension | Injury, poisoning and procedural complications | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| burning sensation | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
|
| hypotonia | Nervous system disorders | Systematic Assessment |
|
| paresthesia | Nervous system disorders | Systematic Assessment |
|
| hyprventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypotension | Vascular disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| urin/defec problems |
|
| Title | Measurements |
|---|---|
|
| urin/defec problems |
|