Prospective, blind-observer, randomised clinical study to investigate and compare the efficacy of intrathecal plain solutions containing Chloroprocaine 1% (50 mg) versus Bupivacaine 0.5% (10mg)
- Conditions
- Patients undergoing elective short duration (<40 min) low abdominal (in gynaecological and urological disciplines) or lower limbs (no more than 1/3 of cases) surgery.MedDRA version: 9.1Level: LLTClassification code 10030858Term: Operation NOS
- Registration Number
- EUCTR2007-000968-25-DE
- Lead Sponsor
- Sintetica SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
•Male/female patients scheduled for short duration (less than 40 min) low abdominal or low extremities (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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the performance of 50 mg of Chloroprocaine 1% in intrathecal anesthesia vs. a gold standard product 10 mg of Bupivacaine 0.5% isobar (Carbostesin 0.5%).;Secondary Objective: Comparison between test and reference in terms of the following parameters:<br>•Time to onset to motor block; the level of motor block is assessed by using the modified Bromage’s scale<br>•Maximum level of sensory block<br>•Resolution (Offset) of sensory block to S1<br>•Resolution of motor block (Bromage score = 0)<br>•Time to unassisted ambulation<br>•Presence of urinary retention<br>•Time when patient asks the first time for analgesia<br>•Time to eligibility for home discharge (for day surgery only)<br>;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)
- Secondary Outcome Measures
Name Time Method