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

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Anesthetics; Bupivacaine; Ropivacaine

Criteria

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.