Back to resultsRopivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
6 mg of ropivacaine
8 mg of ropivacaine
10 mg of ropivacaine
12 mg of ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery
Eligibility 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
Sites / Locations
- Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
6 mg of ropivacaine
8 mg of ropivacaine
10 mg of ropivacaine
12 mg of ropivacaine
Arm Description
6 mg of ropivacaine are used for the spinal anaesthesia
8 mg of ropivacaine are used for the spinal anaesthesia
10 mg of ropivacaine are used for the spinal anaesthesia
12 mg of ropivacaine are used for the spinal anaesthesia
Outcomes
Primary Outcome Measures
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
Secondary Outcome Measures
Spinal anaesthesia characteristics
Hemodynamics consequences
Patient and surgeon satisfaction
Morbidity and mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01005550
Brief Title
Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
Unilateral spinal anaesthesia, Hypobaric anaesthesia, Ropivacaine, Traumatic hip surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
6 mg of ropivacaine
Arm Type
Experimental
Arm Description
6 mg of ropivacaine are used for the spinal anaesthesia
Arm Title
8 mg of ropivacaine
Arm Type
Experimental
Arm Description
8 mg of ropivacaine are used for the spinal anaesthesia
Arm Title
10 mg of ropivacaine
Arm Type
Experimental
Arm Description
10 mg of ropivacaine are used for the spinal anaesthesia
Arm Title
12 mg of ropivacaine
Arm Type
Experimental
Arm Description
12 mg of ropivacaine are used for the spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
6 mg of ropivacaine
Intervention Description
6 mg of ropivacaine are used for the spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
8 mg of ropivacaine
Intervention Description
8 mg of ropivacaine are used for the spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
10 mg of ropivacaine
Intervention Description
10 mg of ropivacaine for the spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
12 mg of ropivacaine
Intervention Description
12 mg of ropivacaine for the spinal anaesthesia
Primary Outcome Measure Information:
Title
Determine the minimum effective ropivacaine dose for unilateral hypobaric spinal anaesthesia during traumatic femoral neck surgery.
Time Frame
1 hour (surgery intervention)
Secondary Outcome Measure Information:
Title
Spinal anaesthesia characteristics
Time Frame
1 hour (surgery intervention)
Title
Hemodynamics consequences
Time Frame
1 hour (surgery intervention)
Title
Patient and surgeon satisfaction
Time Frame
1 hour (surgery intervention)
Title
Morbidity and mortality
Time Frame
During 3 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal MEURET, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23592605
Citation
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.
Results Reference
result
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Ropivacaine Hypobaric Spinal Anaesthesia in Traumatic Hip Surgery
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