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

Anesthesia,Spinal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00358280
• Other study ID #: D0695L00002
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2006
• Last updated: March 25, 2009
• Start date: April 2006
• Est. completion date: September 2006

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anesthesia,Spinal

Intervention

Drug:
• Ropivacaine

• Bupivacaine

Locations

Country	Name	City	State
China	Research Site	Beijing
China	Research Site	Guangzhou
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the duration of sensory block at dermatome T10 level
Secondary	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
Secondary	To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the quality of anaesthesia
Secondary	To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in subject pain during surgery
Secondary	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