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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.