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

• ClinicalTrials.gov Identifier: NCT00358280
• Recruitment Status: Completed
• First Posted: July 31, 2006
• Last Update Posted: March 26, 2009
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Anesthesia,Spinal	Drug: Ropivacaine; Drug: Bupivacaine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 220 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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 Start Date: April 2006
• Actual Study Completion Date: September 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the duration of sensory block at dermatome T10 level
2. 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
3. To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the quality of anaesthesia
4. To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in subject pain during surgery
5. 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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

China

Research Site

Beijing, China

Research Site

Guangzhou, China

Research Site

Shanghai, China

Research Site

Shenyang, China

Research Site

Xi'an, China

Sponsors and Collaborators

AstraZeneca

Investigators

• Study Director: AstraZeneca China Medical Director, MD; AstraZeneca

More Information

• ClinicalTrials.gov Identifier: NCT00358280
• Other Study ID Numbers: D0695L00002
• First Posted: July 31, 2006
• Last Update Posted: March 26, 2009
• Last Verified: March 2009

Keywords provided by AstraZeneca:

Patients ASA category I ～ II; Unilateral Lower limb surgery; Spinal Anesthesia

Additional relevant MeSH terms:

Bupivacaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents