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

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ClinicalTrials.gov Identifier: NCT02152293
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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
Actual Enrollment : 620 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Impact of CLOROTEKAL® on the discharge from hospital [ Time Frame: 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 :
  1. Modalities of spinal anesthesia with CLOROTEKAL® [ Time Frame: During surgery ]
  2. Safety of CLOROTEKAL [ Time Frame: Up to 24 hours after surgery ]
    Percentage and nature of adverse effect (serious or not) after intrathecal anaesthesia with chloroprocaine.

  3. Patients' satisfaction [ Time Frame: 24h after surgery ]
  4. Postoperative patients pain [ Time Frame: During the 24 hours following surgery ]
  5. Rate of unplanned admissions related to anesthesia and/or surgery [ Time Frame: Within the same day than surgery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152293


Locations
France
Nordic Pharma
Paris, France
Sponsors and Collaborators
Nordic Pharma SAS
Investigators
Study Director: Hélène HERMAN-DEMARS, MD Nordic Pharma

Publications:
Responsible Party: Nordic Pharma SAS
ClinicalTrials.gov Identifier: NCT02152293     History of Changes
Other Study ID Numbers: CLOCK
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Chloroprocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents