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

Spinal Anesthesia Clinical Trial

— CLOCK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152293
• Other study ID #: CLOCK
• Status: Completed
• Phase: N/A
• First received: May 23, 2014
• Last updated: May 22, 2015
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• Source: Nordic Pharma SAS
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: French Data Protection Authority
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 620
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Outpatient Surgery
• Spinal Anesthesia

Locations

Country	Name	City	State
France	Nordic Pharma	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Pharma SAS

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Modalities of spinal anesthesia with CLOROTEKAL®		During surgery	No
Secondary	Safety of CLOROTEKAL	Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine.	Up to 24 hours after surgery	Yes
Secondary	Patients' satisfaction		24h after surgery	No
Secondary	Postoperative patients pain		During the 24 hours following surgery	No
Secondary	Rate of unplanned admissions related to anesthesia and/or surgery		Within the same day than surgery	No