Spinal Anaesthesia With Chloroprocaine HCl 1% for Elective Lower Limb Procedures of Short Duration.
Condition: Short Duration Lower Limb Surgery Via Spinal Anaesthesia
Intervention: Chloroprocaine HCl 1%
Intervention description: Intrathecal Route
Intervention MeSH terms: Chloroprocaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study evaluate the effect of 3 doses of Chloroprocaine HCl 1% (30, 40 and 50 mg) for
      spinal anaesthesia in adult patients undergoing short duration elective surgery of the lower
      limb. Patients undergoing elective short-duration lower limb surgery will be randomised into
      3 treatment groups (15 patients per group) to receive one of the 3 single doses of
      Chloroprocaine HCl 1%, i.e. either D1, D2 or D3, via intrathecal injection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Sex, age and surgery: male/female patients, 18-65 years old, scheduled for short
             duration (less than 40 min) lower limb surgery requiring ≥ T12 metameric level of
             sensory block

          2. Body Mass Index (BMI): 18 - 32 kg/m2 inclusive

          3. ASA physical status: I-II

          4. Informed consent: signed written informed consent before inclusion in the study 5.
             Full comprehension: ability to comprehend the full nature and purpose of the study,
             including possible risks and side effects; ability to co-operate with the investigator
             and to comply with the requirements of the entire study.

        Exclusion Criteria:

          1. Physical findings: clinically significant abnormal physical findings which could
             interfere with the objectives of the study. Contraindications to spinal anaesthesia.
             History of neuromuscular diseases to the lower extremities

          2. ASA physical status: III-V

          3. Further anaesthesia: patients expected to require further anaesthesia

          4. Allergy: ascertained or presumptive hypersensitivity to the active principle and/or
             formulations ingredients; ascertained or presumptive hypersensitivity to the ester
             type and major anaesthetics

          5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular,
             respiratory, skin, haematological, endocrine or neurological diseases that may
             interfere with the aim of the study; ascertained psychiatric and neurological
             diseases, sepsis, blood coagulation disorders, severe cardiopulmonary disease, thyroid
             disease, diabetes or other neuropathies.

          6. Investigative drug studies: participation in the evaluation of any investigational
             product for 3 months before this study, calculated from the first day of the month
             following the last visit of the previous study

          7. Drug, alcohol: history of drug or alcohol abuse

          8. Blood donation: blood donations in the 3 months before this study

          9. Pregnancy and lactation: missing or positive pregnancy test at screening, pregnant or
             lactating women

         10. Chronic pain syndromes: patients with chronic pain syndromes (taking opioids,
             antidepressants, anticonvulsant agents or chronic analgesic therapy) 11. Medications:
             medication known to interfere with the extent of spinal blocks for 2 weeks before the
             start of the study. Hormonal contraceptives for females are allowed.