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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date May 23, 2014
First Posted Date June 2, 2014
Last Update Posted Date May 25, 2015
Study Start Date May 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 28, 2014)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 28, 2014)
  • Modalities of spinal anesthesia with CLOROTEKAL® [ Time Frame: During surgery ]
  • 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.
  • Patients' satisfaction [ Time Frame: 24h after surgery ]
  • Postoperative patients pain [ Time Frame: During the 24 hours following surgery ]
  • Rate of unplanned admissions related to anesthesia and/or surgery [ Time Frame: Within the same day than surgery ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Chloroprocaine (CLOROTEKAL®) on Eligibility for Discharge From Hospital After Outpatient Surgery
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Spinal Anesthesia
  • Outpatient Surgery
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 22, 2015)
620
Original Estimated Enrollment
 (submitted: May 28, 2014)
600
Actual Study Completion Date January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02152293
Other Study ID Numbers CLOCK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nordic Pharma SAS
Study Sponsor Nordic Pharma SAS
Collaborators Not Provided
Investigators
Study Director: Hélène HERMAN-DEMARS, MD Nordic Pharma
PRS Account Nordic Pharma SAS
Verification Date May 2015