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Completed

NCT Number: NCT02152293

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

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.

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Key information

Conditions

Spinal Anesthesia Outpatient Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nordic Pharma

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nordic Pharma SAS

Industry

Registry information

Official study 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

Acronym: CLOCK

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2014
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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