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The purpose of this study is to assess, in real life, the efficacy and the eligibility for discharge of a local anesthetic, CLOROTEKAL®, used for spinal anesthesia in short 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.
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| Measure | Description | Time Frame |
|---|---|---|
| Impact of CLOROTEKAL® on the discharge from hospital | 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. | Average time expected around 180 min after the surgery (Lacasse, 2011) |
| Measure | Description | Time Frame |
|---|---|---|
| Modalities of spinal anesthesia with CLOROTEKAL® | During surgery | |
| Safety of CLOROTEKAL | Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for surgery under spinal anesthesia of short duration will be informed about the study and will be asked to participate, from about day -14 (pre-anesthesia consultation) to 24h after the day of surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Hélène HERMAN-DEMARS, MD | Nordic Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordic Pharma | Paris | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21203878 | Background | Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M, Massicotte L. Comparison of bupivacaine and 2-chloroprocaine for spinal anesthesia for outpatient surgery: a double-blind randomized trial. Can J Anaesth. 2011 Apr;58(4):384-91. doi: 10.1007/s12630-010-9450-x. Epub 2011 Jan 4. | |
| 31828611 | Derived |
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| Up to 24 hours after surgery |
| Patients' satisfaction | 24h after surgery |
| Postoperative patients pain | During the 24 hours following surgery |
| Rate of unplanned admissions related to anesthesia and/or surgery | Within the same day than surgery |
| Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study. Adv Ther. 2020 Jan;37(1):541-551. doi: 10.1007/s12325-019-01172-5. Epub 2019 Dec 11. |