Clinical trial NCT00358280: Ropivacaine Versus Bupivacaine 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia,Spinal
Keywords: Patients ASA category I ～ II
Unilateral Lower limb surgery
Spinal Anesthesia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-31
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
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 outcomes:
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
measure: 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
measure: To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in the quality of anaesthesia
measure: To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in subject pain during surgery
measure: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
city: Guangzhou
country: China
facility: Research Site
city: Shanghai
country: China
facility: Research Site
city: Shenyang
country: China
facility: Research Site
city: Xi'an
country: China
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca China Medical Director, MD
role: STUDY_DIRECTOR
References: