NCT02406300

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

March 30, 2015

Last Update Submit

January 27, 2021

Conditions

Hip Fractures

Keywords

Hip FractureRegional AnesthesiaPeripheral Nerve BlocksPost-operative MortalityCognitive DysfunctionQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    up to one year post-operative

Secondary Outcomes (2)

  • Incidence of post-operative delirium

    Up to one week post-operative

  • Quality of Life Recovery

    Up to one year post-operative

Study Arms (2)

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

Procedure: Subarachnoid AnesthesiaDrug: 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

Procedure: PNB/GADrug: ropivacaineDrug: sevoflurane or desflurane

Interventions

Subarachnoid AnesthesiaPROCEDURE
Subarachnoid anesthesia
PNB/GAPROCEDURE
PNB/GA
ropivacaineDRUG
PNB/GA
sevoflurane or desfluraneDRUG
PNB/GA
bupivacaine or levobupivacaineDRUG
Subarachnoid anesthesia

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serviço de Anestesiologia - Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 33238043DERIVED

MeSH Terms

Conditions

Hip FracturesCognitive Dysfunction

Interventions

RopivacaineSevofluraneDesfluraneBupivacaineLevobupivacaine

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsEthyl Ethers

Study Officials

  • Raul Carvalho, MSc

    Serviço de Anestesiologia, Centro Hospitalar do Porto; Faculdade de Medicina, Universidade do Porto

    PRINCIPAL INVESTIGATOR

  • Luís Azevedo, PhD

    Universidade do Porto

    STUDY CHAIR

  • Fernando Abelha, PhD

    Universidade do Porto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Raul Carvalho, MD, MSc

Study Record Dates

First Submitted

March 30, 2015

First Posted

April 2, 2015

Study Start

April 1, 2015

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

PT(1)