Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Spinal Anesthesia, Outpatient Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients seen in pre-anesthesia consultation for ambulatory surgery Patients for whom a spinal anesthesia using CLOROTEKAL® is planned Patients accepting and able to complete a satisfaction self-administered questionnaire Informed patients who accept the computer processing of their medical data and their right of access and correction Exclusion Criteria: Patients with contra-indications to spinal anesthesia (eg decompensated cardiac insufficiency, hypovolemic shock….) Patients with contra-indications to chloroprocaine (hypersensitivity to the active substance, medicinal products of the para-aminobenzoic acid ester group, other ester-type local anaesthetics or to any of the excipients ; Intravenous regional anaesthesia (the anesthetic agent is introduced into the limb and allowed to set in while tourniquets retain the agent within the desired area), serious problems with cardiac conduction, severe anemia) Patients participating or having participated in the previous month in a clinical trial in anesthesiology

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 |