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 characteristicsHemodynamics 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
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