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

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; 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.

• Study Type: Observational
• Enrollment (Actual): 620

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Nordic Pharma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nordic Pharma SAS
• Investigators: Study Director: Hélène HERMAN-DEMARS, MD, Nordic Pharma

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 23, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: CLOCK