Text Size

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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00358280
First received: July 28, 2006
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Anesthesia,Spinal
 Drug: Ropivacaine
Drug: Bupivacaine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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
  • To compare the efficacy of ropivacaine 5 mg/ml and bupivacaine 5 mg/ml in subject pain during surgery
  • 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

Estimated Enrollment: 220
Study Start Date: April 2006
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358280

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

No publications provided

ClinicalTrials.gov Identifier: NCT00358280     History of Changes
Other Study ID Numbers: D0695L00002
Study First Received: July 28, 2006
Last Updated: March 25, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Patients ASA category I ～ II
Unilateral Lower limb surgery
Spinal Anesthesia

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Ropivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013