Anesthesia And Post-operative Mortality After Proximal Femur Fractures
Primary Purpose
Hip Fractures
Status
Terminated
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Subarachnoid Anesthesia
PNB/GA
ropivacaine
sevoflurane or desflurane
bupivacaine or levobupivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Hip Fractures focused on measuring Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life
Eligibility Criteria
Inclusion Criteria:
- Patients admitted wiht a diagnosis of proximal femur fracture (ICD-9 codes 820.0 to 820.9) and submitted to surgical internal fixation of femur or hip prosthesis (ICD-9 codes 7935, 8151 and 8152)
Exclusion Criteria:
- Multiple fractures; polytrauma, active malignancy, ASA(American Society of Anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, contra-indication to general or regional anesthesia
Sites / Locations
- Serviço de Anestesiologia - Centro Hospitalar do Porto
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Subarachnoid anesthesia
PNB/GA
Arm Description
Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used
Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane
Outcomes
Primary Outcome Measures
Survival rate
Secondary Outcome Measures
Incidence of post-operative delirium
Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Quality of Life Recovery
Quality of Life Assessment tools (SF12v2; EQ-5D (EuroQol); Post-operative Quality Recovery Scale) used from 30 days to one year post-operative. Comparing with pre-surgical values
Full Information
NCT ID
NCT02406300
First Posted
March 30, 2015
Last Updated
January 27, 2021
Sponsor
Centro Hospitalar do Porto
Collaborators
Center for Health Technology and Services Research, Universidade do Porto
1. Study Identification
Unique Protocol Identification Number
NCT02406300
Brief Title
Anesthesia And Post-operative Mortality After Proximal Femur Fractures
Official Title
Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Organizational changes made recruitment no longer possible
Study Start Date
April 1, 2015 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Hospitalar do Porto
Collaborators
Center for Health Technology and Services Research, Universidade do Porto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates the effect of anesthesia on mortality after surgical repair of proximal femur fracture.
Patients will receive either a subarachnoid block or a combination of peripheral nerve blocks and light general anesthesia (PNB/GA).
The investigators hypothesis is that a combination of peripheral nerve blocks with an opioid free light anesthesia may have more favourable outcomes.
Both groups will be followed up for assessment of post-operative morbidity and mortality.
Detailed Description
Proximal femur fracture is one of the most common causes of admission in emergency departments. Mortality is high among these patients and is reported to range from 10% at 30 days, up to 32% at one-year post-operative.
Several strategies to reduce mortality have been used, but mortality rate has plateaued since 1998. Attempts to show benefit from regional or general anesthesia have shown inconsistent results. New techniques with peripheral nerve blocks have been used, but their effect on mortality when used as major anesthesia component have not been studied.
The investigators hypothesise that smaller physiologic impact of peripheral nerve blocks associated to light general anesthesia may improve survival rates and reduce short term delirium after proximal femur fracture surgery. Recovery of quality of life will also be assessed.
Patients will be randomized into two groups, being allocated for a subarachnoid anesthesia or a combination of peripheral nerve blocks and light general anesthesia.
Patients will be followed up for short-term post-operative complications such as incidence of delirium, recovery of quality of life and survival up to one year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
Keywords
Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subarachnoid anesthesia
Arm Type
Active Comparator
Arm Description
Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair.
Up to 12.5 mg of bupivacaine or levobupivacaine will be used
Arm Title
PNB/GA
Arm Type
Active Comparator
Arm Description
Patients are submitted to a femoral, a lateral cutaneous nerve of the thigh and an anterior obturator nerve blocks with ropivacaine and an inhalational general anesthesia with sevoflurane or desflurane
Intervention Type
Procedure
Intervention Name(s)
Subarachnoid Anesthesia
Intervention Type
Procedure
Intervention Name(s)
PNB/GA
Intervention Type
Drug
Intervention Name(s)
ropivacaine
Intervention Type
Drug
Intervention Name(s)
sevoflurane or desflurane
Intervention Type
Drug
Intervention Name(s)
bupivacaine or levobupivacaine
Primary Outcome Measure Information:
Title
Survival rate
Time Frame
up to one year post-operative
Secondary Outcome Measure Information:
Title
Incidence of post-operative delirium
Description
Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Time Frame
Up to one week post-operative
Title
Quality of Life Recovery
Description
Quality of Life Assessment tools (SF12v2; EQ-5D (EuroQol); Post-operative Quality Recovery Scale) used from 30 days to one year post-operative. Comparing with pre-surgical values
Time Frame
Up to one year post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients admitted wiht a diagnosis of proximal femur fracture (ICD-9 codes 820.0 to 820.9) and submitted to surgical internal fixation of femur or hip prosthesis (ICD-9 codes 7935, 8151 and 8152)
Exclusion Criteria:
Multiple fractures; polytrauma, active malignancy, ASA(American Society of Anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, contra-indication to general or regional anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Carvalho, MSc
Organizational Affiliation
Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luís Azevedo, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fernando Abelha, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Study Chair
Facility Information:
Facility Name
Serviço de Anestesiologia - Centro Hospitalar do Porto
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
12. IPD Sharing Statement
Citations:
PubMed Identifier
33238043
Citation
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Results Reference
derived
Learn more about this trial
Anesthesia And Post-operative Mortality After Proximal Femur Fractures
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