NCT01005550

Brief Summary

This is a prospective, monocentric, randomized study, comparing the effectiveness and tolerance of four different dosages of hypobaric ropivacaine for unilateral spinal anaesthesia during traumatic femoral neck surgery in the elderly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

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

April 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 28, 2019

Status Verified

December 1, 2010

Enrollment Period

2.9 years

First QC Date

August 14, 2009

Last Update Submit

May 23, 2019

Conditions

Femoral Neck Fracture

Keywords

Unilateral spinal anaesthesiaHypobaric anaesthesiaRopivacaineTraumatic hip surgery

Outcome Measures

Primary Outcomes (1)

  • Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.

    1 hour (surgery intervention)

Secondary Outcomes (4)

  • Spinal anaesthesia characteristics

    1 hour (surgery intervention)

  • Hemodynamics consequences

    1 hour (surgery intervention)

  • Patient and surgeon satisfaction

    1 hour (surgery intervention)

  • Morbidity and mortality

    During 3 days after surgery

Study Arms (4)

6 mg of ropivacaine

EXPERIMENTAL

6 mg of ropivacaine are used for the spinal anaesthesia

Drug: 6 mg of ropivacaine

8 mg of ropivacaine

EXPERIMENTAL

8 mg of ropivacaine are used for the spinal anaesthesia

Drug: 8 mg of ropivacaine

10 mg of ropivacaine

EXPERIMENTAL

10 mg of ropivacaine are used for the spinal anaesthesia

Drug: 10 mg of ropivacaine

12 mg of ropivacaine

EXPERIMENTAL

12 mg of ropivacaine are used for the spinal anaesthesia

Drug: 12 mg of ropivacaine

Interventions

6 mg of ropivacaineDRUG

6 mg of ropivacaine are used for the spinal anaesthesia

6 mg of ropivacaine
8 mg of ropivacaineDRUG

8 mg of ropivacaine are used for the spinal anaesthesia

8 mg of ropivacaine
10 mg of ropivacaineDRUG

10 mg of ropivacaine for the spinal anaesthesia

10 mg of ropivacaine
12 mg of ropivacaineDRUG

12 mg of ropivacaine for the spinal anaesthesia

12 mg of ropivacaine

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older than 70
  • dorsal decubitus surgery
  • ASA score 1, 2, 3
  • MMS score \> or equal to 25

You may not qualify if:

  • local anesthetic allergy
  • MMS score lower than 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon

Lyon, 69, France

Location

Related Publications (1)

  • Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deleat-Besson R, Rousselet B, Thouverez B, Zadam A, Allaouchiche B, Boselli E. Hypobaric spinal anesthesia with ropivacaine plus sufentanil for traumatic femoral neck surgery in the elderly: a dose-response study. Anesth Analg. 2013 Jul;117(1):259-64. doi: 10.1213/ANE.0b013e31828f29f8. Epub 2013 Apr 16.

    PMID: 23592605RESULT

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Pascal MEURET, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

November 2, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 28, 2019

Record last verified: 2010-12

Locations

FR(1)