Clinical trial NCT02152293: Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Outpatient Surgery
Lead sponsor: Nordic Pharma SAS
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Impact of CLOROTEKAL® on the discharge from hospital
timeFrame: Average time expected around 180 min after the surgery (Lacasse, 2011)
Secondary outcomes:
measure: Modalities of spinal anesthesia with CLOROTEKAL®
timeFrame: During surgery
measure: Safety of CLOROTEKAL
timeFrame: Up to 24 hours after surgery
measure: Patients' satisfaction
timeFrame: 24h after surgery
measure: Postoperative patients pain
timeFrame: During the 24 hours following surgery
measure: Rate of unplanned admissions related to anesthesia and/or surgery
timeFrame: Within the same day than surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Nordic Pharma
Study officials:
affiliation: Nordic Pharma
name: Hélène HERMAN-DEMARS, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.