Observational Prospective Study on 2-Chloroprocaine Hydrochloride 1% Safety in Intrathecal Anaesthesia

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational study

Study drug and medical condition

• Name of medicine, other:
  Ampres, Decelex, Clorotekal
• Medical condition to be studied:
  Anaesthetic complication neurological

Population studied

• Short description of the study population:
  Male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  380

Study design details

• Main study objective:
  The present study aims to evaluate the relationship between spinal block with 1% solution of 2-chloroprocaine hydrochloride and the onset of all possible neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome (CES).
• Outcomes:
  The primary endpoint is the incidence of neurological complications (Transient and Permanent complications, e.g. transient neurological symptoms, arachnoiditis, cauda equina syndrome). Two follow-up questionnaires are foreseen, at 24 h and 7 days after time of spinal injection, to gather all possible neurological complications, with particular attention to TNS and CES. Other endpoints is the incidents of other adverse events (AEs) e.g.: paraesthesia, haemorrhage, headache, micturition/defecation difficulties, tiredness, nausea/vomiting, dizziness, hypotension, bradycardia, Post Dural Puncture Headache (PDPH), epidural haematoma, anterior spinal artery syndrome,meningitis.
• Data analysis plan:
  The main goal will be the incidence of:- Transient Neurologic Symptoms (TNS) at 24 h and 7 days after Tsp- Cauda Equina Syndrome (CES) at 24 h and 7 days after TspThe above analysis will be stratified, if numbers permitted, according to the following age groups: 18-64 and >65 years old.

Documents

Study results

Summary Report_CHL1-01-2012-M

Study publications

Zaric D, Pace NL. Transient neurologic symptoms (TNS) following spinal anaesthe…

Lacasse MA, Roy JD, Forget J, Vandenbroucke F, Seal RF, Beaulieu D, McCormack M…

Camponovo C, Wulf H, Ghisi D, Fanelli A, Riva T, Cristina D, Vassiliou T, Lesch…

Hejtmanek MR, Pollock JE. Chloroprocaine for spinal anaesthesia: a retrospectiv…

Vaghadia H, Neilson G, Lennox PH. Selective spinal anesthesia for outpatient tr…