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

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia,Spinal
• Intervention / Treatment: Drug: Ropivacaine; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment: 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Research Site
  • Guangzhou, China
    • Research Site
  • Shanghai, China
    • Research Site
  • Shenyang, China
    • Research Site
  • Xi'an, China
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: AstraZeneca China Medical Director, MD, AstraZeneca

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Study Completion (Actual): September 1, 2006

Study Registration Dates

• First Submitted: July 28, 2006
• First Submitted That Met QC Criteria: July 28, 2006
• First Posted (Estimate): July 31, 2006

Study Record Updates

• Last Update Posted (Estimate): March 26, 2009
• Last Update Submitted That Met QC Criteria: March 25, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: Spinal Anesthesia; Patients ASA category I ～ II; Unilateral Lower limb surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine
• Other Study ID Numbers: D0695L00002