Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

NCT ID: NCT01005550

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Neck Fracture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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6 mg of ropivacaine

6 mg of ropivacaine are used for the spinal anaesthesia

Group Type EXPERIMENTAL

6 mg of ropivacaine

Intervention Type DRUG

6 mg of ropivacaine are used for the spinal anaesthesia

8 mg of ropivacaine

8 mg of ropivacaine are used for the spinal anaesthesia

Group Type EXPERIMENTAL

8 mg of ropivacaine

Intervention Type DRUG

8 mg of ropivacaine are used for the spinal anaesthesia

10 mg of ropivacaine

10 mg of ropivacaine are used for the spinal anaesthesia

Group Type EXPERIMENTAL

10 mg of ropivacaine

Intervention Type DRUG

10 mg of ropivacaine for the spinal anaesthesia

12 mg of ropivacaine

12 mg of ropivacaine are used for the spinal anaesthesia

Group Type EXPERIMENTAL

12 mg of ropivacaine

Intervention Type DRUG

12 mg of ropivacaine for the spinal anaesthesia

Interventions

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6 mg of ropivacaine

6 mg of ropivacaine are used for the spinal anaesthesia

Intervention Type DRUG

8 mg of ropivacaine

8 mg of ropivacaine are used for the spinal anaesthesia

Intervention Type DRUG

10 mg of ropivacaine

10 mg of ropivacaine for the spinal anaesthesia

Intervention Type DRUG

12 mg of ropivacaine

12 mg of ropivacaine for the spinal anaesthesia

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* local anesthetic allergy
* spinal anaesthetic exclusion
* MMS score lower than 25
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal MEURET, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 23592605 (View on PubMed)

Other Identifiers

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2008.519

Identifier Type: -

Identifier Source: org_study_id

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