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

NCT02152293 | Completed

• 1 other identifier: CLOCK
• Study Type: observational
• Target: 620
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Outpatient Surgery

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Modalities of spinal anesthesia with CLOROTEKAL®

  During surgery

• Safety of CLOROTEKAL

  Up to 24 hours after surgery

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordic Pharma SAS: lead

Study Sites (1)

Nordic Pharma

Paris, France

Location

Related Publications (2)

• 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.

  PMID: 21203878 BACKGROUND

• Capdevila X, Aveline C, Delaunay L, Bouaziz H, Zetlaoui P, Choquet O, Jouffroy L, Herman-Demars H, Bonnet F. Impact of Chloroprocaine on the Eligibility for Hospital Discharge in Patients Requiring Ambulatory Surgery Under Spinal Anesthesia: An Observational Multicenter Prospective Study. Adv Ther. 2020 Jan;37(1):541-551. doi: 10.1007/s12325-019-01172-5. Epub 2019 Dec 11.

  PMID: 31828611 DERIVED

Study Officials

• Hélène HERMAN-DEMARS, MD

  Nordic Pharma

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

FR (1)