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

Completed

• Conditions: Spinal Anesthesia; Outpatient Surgery

• Registration Number: NCT02152293
• Lead Sponsor: Nordic Pharma SAS

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-23
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 620

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nordic Pharma; 🇫🇷 Paris, France