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Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery

Information source: Hospices Civils de Lyon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Femoral Neck Fracture

Intervention: 6 mg of ropivacaine (Drug); 8 mg of ropivacaine (Drug); 10 mg of ropivacaine (Drug); 12 mg of ropivacaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Hospices Civils de Lyon

Official(s) and/or principal investigator(s):
Pascal MEURET, MD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome:

Spinal anaesthesia characteristics

Hemodynamics consequences

Patient and surgeon satisfaction

Morbidity and mortality

Eligibility

Minimum age: 70 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Hospices Civils de Lyon, Lyon 69, France
Additional Information

Starting date: April 2009
Last updated: March 8, 2012

Page last updated: August 23, 2015

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