Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery (CLOCK)
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|ClinicalTrials.gov Identifier: NCT02152293|
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 25, 2015
|Condition or disease|
|Spinal Anesthesia Outpatient Surgery|
This is a longitudinal, observational, prospective, multicentre, national study, conducted in France, from a representative sample of physician anesthetists.
The efficacy and safety in real life of CLOROTEKAL® will be assessed in patients undergoing a short outpatient surgery under spinal anesthesia. Data will be collected by the physician during two visits (pre-anesthesia and per-postoperative consultation). Additional data regarding the patient's perception (safety, pain and satisfaction) will be collected using a self-questionnaire.
|Study Type :||Observational|
|Actual Enrollment :||620 participants|
|Official Title:||Pharmacoepidemiology Study on Real Life Impact of Chloroprocaine (CLOROTEKAL®) on the Eligibility for Discharge From Hospital of Patients Requiring Short Outpatient Surgery Under Spinal Anesthesia|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
- Impact of CLOROTEKAL® on the discharge from hospital [ Time Frame: Average time expected around 180 min after the surgery (Lacasse, 2011) ]
Time to eligibility for discharge from hospital measured as the time between the intrathecal injection and achieving the criteria of Lacasse.
This period will be described globally (average time) and by groups: <180 min ; <240 min ; <300 min ; <360 min ; > 360 min.
- Modalities of spinal anesthesia with CLOROTEKAL® [ Time Frame: During surgery ]
- Safety of CLOROTEKAL [ Time Frame: Up to 24 hours after surgery ]Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine.
- Patients' satisfaction [ Time Frame: 24h after surgery ]
- Postoperative patients pain [ Time Frame: During the 24 hours following surgery ]
- Rate of unplanned admissions related to anesthesia and/or surgery [ Time Frame: Within the same day than surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152293
|Study Director:||Hélène HERMAN-DEMARS, MD||Nordic Pharma|