Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Anesthesia,Spinal

Treatments

Drug: Bupivacaine

Drug: Ropivacaine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00358280

D0695L00002

Details and patient eligibility

About

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 bupivacaine 5 mg/ml when used for spinal anaesthesia in patients undergoing unilateral lower limb surgery.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
18.5 ≤ BMI ≤ 23.9

Exclusion criteria

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.