Anesthesia And Post-operative Mortality After Proximal Femur Fractures

January 27, 2021 updated by: Raul Carvalho, Centro Hospitalar do Porto

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: ropivacaine
Procedure: PNB/GA
Drug: sevoflurane or desflurane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate
Time Frame: up to one year post-operative
up to one year post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of post-operative delirium
Time Frame: Up to one week post-operative
Measured with the 3D-CAM Questionaire (Confusion Assessment Method)
Up to one week post-operative
Quality of Life Recovery
Time Frame: Up to one year post-operative
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
Up to one year post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Hospitalar do Porto

Collaborators

Universidade do Porto
Center for Health Technology and Services Research

Investigators

  • Principal Investigator: Raul Carvalho, MSc, Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto
  • Study Chair: Luís Azevedo, PhD, Universidade do Porto
  • Study Chair: Fernando Abelha, PhD, Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

March 30, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 226-14 (165-DEFI/193-CES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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