NCT00150865

Brief Summary

Compare lumbar plexus block with ropivacaine 0.475%, 0.4 ml/kg to saline. Each group randomized, includes 30 patients. block performed preoperatively Surgery under general anesthesia. Postoperative evaluation of pain (VAS) as first endpoint, and also morphine consumption via PCA device. Follow-up : 24h. Expectation : sizeable reduction of pain with block, of duration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Sep 2001

Shorter than P25 for not_applicable pain

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

November 1, 2017

Status Verified

September 1, 2005

First QC Date

September 7, 2005

Last Update Submit

October 30, 2017

Conditions

PainPostoperative

Keywords

ropivacaineposterior lumbar plexus blockhip arthroplasyanalgesiapostoperative

Outcome Measures

Primary Outcomes (1)

  • decrease of postoperative pain

Secondary Outcomes (2)

  • decrease in morphine consumption

  • duraration of analgesic effect

Interventions

ropivacaineDRUG

Eligibility Criteria

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

You may qualify if:

  • adults
  • ASA 1-3

You may not qualify if:

  • cognitive impairement
  • ASA IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAgnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • laurent beydon, MD

    University Hospital, Angers

    STUDY DIRECTOR

  • ibrahim okais, MD

    Clinique St Leonard

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 8, 2005

Study Start

September 1, 2001

Study Completion

March 1, 2002

Last Updated

November 1, 2017

Record last verified: 2005-09