Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
Phase 4
Completed
- Conditions
- Femoral Neck Fracture
- Interventions
- Drug: 6 mg of ropivacaineDrug: 8 mg of ropivacaineDrug: 10 mg of ropivacaineDrug: 12 mg of ropivacaine
- Registration Number
- NCT01005550
- Lead Sponsor
- Hospices Civils de Lyon
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 6 mg of ropivacaine 6 mg of ropivacaine 6 mg of ropivacaine are used for the spinal anaesthesia 8 mg of ropivacaine 8 mg of ropivacaine 8 mg of ropivacaine are used for the spinal anaesthesia 10 mg of ropivacaine 10 mg of ropivacaine 10 mg of ropivacaine are used for the spinal anaesthesia 12 mg of ropivacaine 12 mg of ropivacaine 12 mg of ropivacaine are used for the spinal anaesthesia
- Primary Outcome Measures
Name Time Method Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery. 1 hour (surgery intervention)
- Secondary Outcome Measures
Name Time Method Patient and surgeon satisfaction 1 hour (surgery intervention) Morbidity and mortality During 3 days after surgery Spinal anaesthesia characteristics 1 hour (surgery intervention) Hemodynamics consequences 1 hour (surgery intervention)
Trial Locations
- Locations (1)
Hospices Civils de Lyon
🇫🇷Lyon, France