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Organizational changes made recruitment no longer possible
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| Name | Class |
|---|---|
| Center for Health Technology and Services Research | OTHER |
| Universidade do Porto | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subarachnoid Anesthesia | Procedure |
| ||
| PNB/GA |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate | up to one year post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-operative delirium | Measured with the 3D-CAM Questionaire (Confusion Assessment Method) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raul Carvalho, MSc | Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto | Principal Investigator |
| LuÃs Azevedo, PhD | Universidade do Porto | Study Chair |
| Fernando Abelha, PhD | Universidade do Porto | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Serviço de Anestesiologia - Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33238043 | Derived | 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. |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077149 | Sevoflurane |
| D000077335 | Desflurane |
| D002045 | Bupivacaine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| ropivacaine | Drug |
|
| sevoflurane or desflurane | Drug |
|
| bupivacaine or levobupivacaine | Drug |
|
| Up to one year post-operative |
| D007869 |
| Leg Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000588 |
| Amines |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D005019 | Ethyl Ethers |