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NCT01005550 Clinical Trial

Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

Femoral Neck Fracture Clinical Trial

Official title:
Determining the Minimum Effective Ropivacaine Dose for Unilateral Hypobaric Spinal Anaesthesia During Traumatic Femoral Neck Surgery in the Aged Person: Prospective Comparative Randomized Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01005550
Other study ID # 2008.519
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2009
Est. completion date March 2012

Study information
Verified date December 2010
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 64
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 6 mg of ropivacaine
6 mg of ropivacaine are used for the spinal anaesthesia
• 8 mg of ropivacaine
8 mg of ropivacaine are used for the spinal anaesthesia
• 10 mg of ropivacaine
10 mg of ropivacaine for the spinal anaesthesia
• 12 mg of ropivacaine
12 mg of ropivacaine for the spinal anaesthesia

Locations
Country Name City State
France Hospices Civils de Lyon Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

References & Publications (1)

Lilot M, Meuret P, Bouvet L, Caruso L, Dabouz R, Deléat-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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery. 1 hour (surgery intervention)
Secondary Spinal anaesthesia characteristics 1 hour (surgery intervention)
Secondary Hemodynamics consequences 1 hour (surgery intervention)
Secondary Patient and surgeon satisfaction 1 hour (surgery intervention)
Secondary Morbidity and mortality During 3 days after surgery
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