NCT00358280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

First QC Date

July 28, 2006

Last Update Submit

March 25, 2009

Conditions

Anesthesia,Spinal

Keywords

Patients ASA category I ～ IIUnilateral Lower limb surgerySpinal Anesthesia

Outcome Measures

Primary Outcomes (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 Outcomes (5)

  • 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

Interventions

RopivacaineDRUG
BupivacaineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • ≤ BMI ≤ 23.9

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Research Site

Beijing, China

Location

Research Site

Guangzhou, China

Location

Research Site

Shanghai, China

Location

Research Site

Shenyang, China

Location

Research Site

Xi'an, China

Location

MeSH Terms

Interventions

RopivacaineBupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • AstraZeneca China Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 28, 2006

First Posted

July 31, 2006

Study Start

April 1, 2006

Study Completion

September 1, 2006

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

CN(5)