Outpatient Surgery, Spinal Anesthesia
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Nordic Pharma SAS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of CLOROTEKAL® on the discharge from hospital | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modalities of spinal anesthesia with CLOROTEKAL® | During surgery | — |
| Safety of CLOROTEKAL | Up to 24 hours after surgery | Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine. |
| 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 | — |
Countries
France
Outcome results
None listed