patients undergoing elective short-duration (< 40 min) in low abdominal (gynaecology and urology disciplines) or lower limbs (no more than 1/3 of cases) surgery under spinal anaesthesia. MedDRA version: 9.1 Level: LLT Classification code 10041536 Term: Spinal anaesthesia
Conditions
Interventions
Trade Name: Chloroprocain 1%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Chloroprocaine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Tr
Sponsors
SINTETICA ITALIA S.R.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male/female patients scheduled for short duration (less than 40 min) low abdominal or lower limbs (no more than 1/3 of cases) surgery under spinal anaesthesia, 18-80 years old; 18≤BMI≤32 kg/m2; ASA physical status I-II; 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; Signed written informed consent prior to inclusion in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Clinically relevant abnormalities at ECG (12 leads); Clinically relevant abnormal physical findings and clinically relevant abnormal laboratory values indicative of physical illness/es that in the opinion of the Investigator might interfere with the aim of the study Ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients Ascertained or presumptive hypersensitivity to the amide type of anaesthetics ASA physical status III, IV or V; Patients requiring further anaesthesia (i.e. gas products); Lactating females; Positive pregnancy test at screening History of neuromuscular diseases to the lower extremities, Contraindication to spinal anaesthesia Participation in the evaluation of any drug within 3 months prior to screening; Blood donations during the 3 months prior to this study; History of drug, or alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the performance of 50 mg of Chloroprocaine 1% in intrathecal anaesthesia vs. a gold standard product 10 mg of Bupivacaine 0.5% isobar;Secondary Objective: Comparison between test and reference in terms of the following parameters: Time to onset to motor block; the level of motor block is assessed by using the modified Bromage?s scale Maximum level of sensory block Resolution (Offset) of sensory block to S1 Resolution of motor block (Bromage score = 0) Time to unassisted ambulation Presence of urinary retention requiring catheterisation Time when patient asks the first time for analgesia Time to eligibility for home discharge (for day surgery only);Primary end point(s): To determine the non inferiority of 50 mg Chloroprocaine 1% versus the 10 mg bupivacaine 0.5% in terms of the onset of surgical anaesthesia, i.e. in terms of the time to achieve the sensory block at T10 (assessed by the loss of pin-prick sensation) | — |
Countries
Germany, Italy
Outcome results
None listed