Hip FracturesNCT02406300
Anesthesia And Post-operative Mortality After Proximal Femur Fractures
A study testing Subarachnoid Anesthesia, PNB/GA and ropivacaine in people with Hip Fractures, run by Centro Hospitalar do Porto at 1 site in Portugal.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Subarachnoid Anesthesia, PNB/GA and ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Apr 2015to 31 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Serviço de Anestesiologia - Centro Hospitalar do Porto
Porto, 4099-001
About this study
Official title: Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Hip Fractures
- Being tested
- Subarachnoid Anesthesia, PNB/GA, ropivacaine, sevoflurane or desflurane, bupivacaine or levobupivacaine
- Keywords
- Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life
- Medical subject headings
- Hip Fractures, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subarachnoid AnesthesiaProcedure or surgery
PNB/GAProcedure or surgery
ropivacaineDrug
sevoflurane or desfluraneDrug
bupivacaine or levobupivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Subarachnoid anesthesia | Active comparator | Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair.
Up to 12.5 mg of bupivacaine or levobupivacaine will be used Receives: Procedure: Subarachnoid Anesthesia; Drug: bupivacaine or levobupivacaine |
| PNB/GA | Active comparator | 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 Receives: Procedure: PNB/GA; Drug: ropivacaine; Drug: sevoflurane or desflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
Measured: up to one year post-operative
Secondary outcomes (2)
Incidence of post-operative delirium
Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Measured: Up to one week post-operative
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
Measured: Up to one year post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start1 Apr 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Why it stopped: Organizational changes made recruitment no longer possible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Health Technology and Services Research, Universidade do Porto
- Responsible party
- Principal investigator, Raul Carvalho, Centro Hospitalar do Porto
- Investigators
- Raul Carvalho, MSc, Principal investigator, Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do PortoLuís Azevedo, PhD, Study chair, Universidade do PortoFernando Abelha, PhD, Study chair, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406300
- Sponsor's protocol ID
- 226-14 (165-DEFI/193-CES)
- Status last verified
- Jan 2021
- First submitted
- 30 Mar 2015
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution Of Anesthesia Technique For Post-operative Mortality Reduction After Proximal Femur Fractures Surgical Treatment - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02406300
- Acronym / sponsor ID
- 226-14 (165-DEFI/193-CES)
- Conditions
- Hip Fractures
- Keywords
- Hip Fracture, Regional Anesthesia, Peripheral Nerve Blocks, Post-operative Mortality, Cognitive Dysfunction, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Organizational changes made recruitment no longer possible
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centro Hospitalar do PortoUniversity, hospital or other
- Collaborators
- Center for Health Technology and Services Research, Universidade do Porto
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid anesthesia | Active comparator | Procedure: Subarachnoid Anesthesia, Drug: bupivacaine or levobupivacainePatients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used |
| PNB/GA | Active comparator | Procedure: PNB/GA, Drug: ropivacaine, Drug: sevoflurane or desfluranePatients 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subarachnoid Anesthesia | Procedure or surgery | Subarachnoid anesthesia |
| PNB/GA | Procedure or surgery | PNB/GA |
| ropivacaine | Drug | PNB/GA |
| sevoflurane or desflurane | Drug | PNB/GA |
| bupivacaine or levobupivacaine | Drug | Subarachnoid anesthesia |
Primary outcome
Survival rate
Time frame: up to one year post-operative
2 secondary outcomes
Incidence of post-operative delirium
Time frame: Up to one week post-operative
Quality of Life Recovery
Time frame: Up to one year post-operative
Results and safety
The study was stopped early (reason given: Organizational changes made recruitment no longer possible). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Derived from this study: PubMed 33238043Guay 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raul Carvalho, MSc principal investigator
Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto
Luís Azevedo, PhD study chair
Universidade do Porto
Fernando Abelha, PhD study chair
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subarachnoid Anesthesia, PNB/GA and ropivacaine in people with Hip Fractures, run by Centro Hospitalar do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Organizational changes made recruitment no longer possible). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: up to one year post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02406300, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.