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Ropivacaine

Phase 3

Anesthesia,Spinal | Small molecule | Pain |AstraZeneca PLC|Last Updated: Mar 26, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

Ropivacaine · 1 trial · 1 indication

Phase 3 1
NCT00358280Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb SurgeryAnesthesia,Spinal
COMPLETED220 Analytics
PHASE3COMPLETED
Ropivacaine Versus Bupivacaine for Spinal Anaesthesia in Patients Undergoing Unilateral Lower Limb Surgery
Anesthesia,Spinal
NCT00358280220
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
RopivacaineDRUG -
BupivacaineDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites5

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: * Contraindicat...

Countries:China
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Frequently asked questions about Ropivacaine

What is Ropivacaine used for?

Ropivacaine is used for anesthesia, specifically spinal anesthesia. It is being studied for use in patients undergoing unilateral lower limb surgery. The drug is in Phase 3 clinical development and is being developed by AstraZeneca PLC.

What does Ropivacaine target?

Ropivacaine is a small molecule anesthetic. It works by blocking nerve impulses, providing local anesthesia. The specific molecular target is not disclosed in the available information.

Who makes Ropivacaine?

Ropivacaine is being developed by AstraZeneca PLC, a pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 3 clinical trials for spinal anesthesia.

What phase is Ropivacaine in?

Ropivacaine is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 3 clinical trial has been completed, but the drug remains under investigation.

What clinical trials is Ropivacaine in?

Ropivacaine has one completed Phase 3 clinical trial with the identifier NCT00358280. This trial compared Ropivacaine to Bupivacaine for spinal anesthesia in patients undergoing unilateral lower limb surgery. The trial enrolled 220 participants in China.

Is Ropivacaine the same as Bupivacaine?

No, Ropivacaine is not the same as Bupivacaine. They are different drugs. In a clinical trial, Ropivacaine was compared to Bupivacaine for spinal anesthesia, indicating they are distinct anesthetic agents being evaluated for similar uses.