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TerminatedNCT02406300Updated Feb 1, 2021

Anesthesia And Post-operative Mortality After Proximal Femur Fractures

An interventional study of Subarachnoid Anesthesia and PNB/GA in Hip Fractures, sponsored by Centro Hospitalar do Porto. Terminated at 1 site in Portugal. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Centro Hospitalar do Porto · Not applicable, Interventional, and Treatment

Why this study was terminated
Organizational changes made recruitment no longer possible
Phase
Not applicable
Study type
Interventional
Enrollment
57
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies testing ropivacaine in Hip Fractures — none open to participants now, none under way, none of them phase 3. Ropivacaine · Hip Fractures.

Enrollment
7th of 12
57 · median 59
Started
2015
the only one that year
No phase
6 of 12
none open now
Registered
6th of 12
by date
Lead sponsor
1 of 12
Centro Hospitalar do Porto

Among the 12 studies testing ropivacaine in Hip Fractures, this one is the 7th largest by enrollment, is the only one that started in 2015, is one of 6 with no phase, and was the 6th registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phasethis study6 · 0 open
Phase 46 · 0 open

By the year they started

First in 2008; this study’s year is marked. 1 started in 2015.

Tested beside ropivacaine

Size and results

Median enrollment 59 across the 12 interventional studies. Of the 10 that completed or were terminated, 2 (20%) have results posted.

Download CSVWith an account: the 12 studies testing ropivacaine in Hip Fractures as a file.
02

Study 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.

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.

03

Conditions studied

  • Hip Fractures

Keywords

  • Hip Fracture
  • Regional Anesthesia
  • Peripheral Nerve Blocks
  • Post-operative Mortality
  • Cognitive Dysfunction
  • Quality of Life
04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Multiple fractures; polytrauma, active , ASA(American Society of Anesthesia) status 5, antiplatelet drugs (other than aspirin) in the previous 5 days, known allergies to local anesthetics, to general or regional anesthesia
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
57 participants (actual)

Study arms

  • Active comparator
    Subarachnoid anesthesia

    Patients submitted to subarachnoid anesthesia for proximal femur fracture surgical repair. Up to 12.5 mg of bupivacaine or levobupivacaine will be used

    Procedure: Subarachnoid Anesthesia · Drug: bupivacaine or levobupivacaine

  • Active comparator
    PNB/GA

    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

    Procedure: PNB/GA · Drug: ropivacaine · Drug: sevoflurane or desflurane

Interventions

  • ProcedureSubarachnoid Anesthesia
  • ProcedurePNB/GA
  • Drugsevoflurane or desflurane
  • Drugbupivacaine or levobupivacaine
06

What researchers measure

Primary outcomes

  1. Survival rate

    Time frame: up to one year post-operative

Secondary outcomes

  1. Incidence of post-operative delirium

    Measured with the 3D-CAM Questionaire (Confusion Assessment Method)

    Time frame: Up to one week post-operative

  2. 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

    Time frame: Up to one year post-operative

07

Study locations

1 site
  • Serviço de Anestesiologia - Centro Hospitalar do Porto
    Porto, 4099-001, Portugal
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02406300
Lead sponsor
Centro Hospitalar do Porto
Collaborators
Center for Health Technology and Services Research, Universidade do Porto
Responsible party
Raul Carvalho (Raul Carvalho, MD, MSc, Centro Hospitalar do Porto) — Principal investigator
First posted
Apr 2, 2015
Start date
Apr 1, 2015
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016
Last update
Feb 1, 2021

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ropivacaine

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