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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia,Spinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Ropivacaine

Intervention Type DRUG

Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No