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% (10 mg) - ND

SINTETICA ITALIA S.R.L.0 sites120 target enrollmentJune 24, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: 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.
Sponsor: SINTETICA ITALIA S.R.L.
Enrollment: 120
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

June 24, 2008

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

SINTETICA ITALIA S.R.L.

•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

•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