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

Nordic Pharma

Status: Completed

Conditions: Outpatient Surgery; Spinal Anesthesia

Study type: Observational

Funder types: Industry

Identifiers

NCT02152293

CLOCK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 620 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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