Status:
COMPLETED
Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery
Lead Sponsor:
AstraZeneca
Conditions:
Anesthesia,Spinal
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the efficacy, duration of motor block until return to normal function in the non-operated leg after the start of injection, of ropivacaine 5 mg/ml and bupivacai...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- Men or women, 18 years £ age £ 70 years
- Patient scheduled for unilateral lower limb surgery with an estimated duration \< 2 hours under spinal anaesthesia
- ASA category I \~ II
- 5 ≤ BMI ≤ 23.9
Exclusion
- Contraindications to spinal anaesthesia, such as local infections, generalised septicaemia, platelet and clotting factor abnormalities, significant neurological disease with motor or sensory deficit, diagnosed increased intracranial pressure
- A known history of allergy, sensitivity or any other form of reaction to local anaesthetics of amide type
- Suspected inability to comply with the study procedures, including language difficulties or medical history and/or concomitant disease, as judged by the investigator
- Psychiatric history or any other concomitant disease which may lead to unreliability in clinical assessments, as judged by the investigator
- Significant alcohol, drug or medication abuse, as judged by the investigator
- Women who are pregnant or lactating or women of child bearing potential who are not practising adequate contraception or have positive urine pregnancy test (a urine Human chorionic gonadotropin \[HCG\] analysis)
- Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- Previous enrolment in the present study
- Participation in a clinical study during the last 3 months
- Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subjects' safety or successful participation in the study.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00358280
Start Date
April 1 2006
End Date
September 1 2006
Last Update
March 26 2009
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Beijing, China
2
Research Site
Guangzhou, China
3
Research Site
Shanghai, China
4
Research Site
Shenyang, China