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

Condition(s) targeted: Anesthesia,Spinal

Intervention: Ropivacaine (Drug); Bupivacaine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca China Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: A Randomised, Double-Blind, Multi-Centre, Parallel Group Study Comparing Efficacy and Safety of 5 mg/ml Ropivacaine and 5 mg/ml Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome:

To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the duration of sensory block at dermatome T10 level

To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the onset time of sensory block and motor block respectively

To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the quality of anaesthesia

To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in subject pain during surgery

To determine the safety of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml by evaluating the incidence and severity of adverse events, blood pressure, pulse rate and blood loss

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Research Site, Beijing, China

Research Site, Guangzhou, China

Research Site, Shanghai, China

Research Site, Shenyang, China

Research Site, Xi'an, China

Starting date: April 2006
Last updated: March 25, 2009