Combined Plexus Block for Hip Fracture Surgery.

July 17, 2018 updated by: University Hospital, Montpellier

Is the Combined Plexus Block a Real Alternative for Hip Fracture Surgery in the Elderly? A Comparison With General Anesthesia and Continuous Spinal Anesthesia Using a Propensity Score in a Retrospective Cohort Study.

Hip fracture surgery requires high risk anesthetic procedure for elderly patients (1). General anesthesia, continuous spinal anesthesia and peripheral nerve blocks are three anesthetic techniques possible. Continuous spinal anesthesia has proven its efficacity to provide an intraoperative haemodynamic stability wich guarantees good patients outcomes (2), in comparison with general anesthesia but there is poor evidence in the literature concerning the use of peripheral nerve blocks.

The primary objective of this study was to compare intraoperative haemodynamic stability provides by peripheral nerve block versus general anesthesia and continuous spinal anesthesia.

Secondary outcomes included : use of vasoactive drugs, opioids consumption, lengh of stay and inhospital mortality.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After receiving the ethic approval from the "CERAR", the investigators retrospectively identified all patients who underwent hip fracture surgery from January 1 2015, to December 31, 2016 in the CHU of Montpellier. The exclusion criteria were: multiple trauma victims, two hip fractures in the same patient and single shot spinal anesthesia. In our institution the investigators used to perform three types of anesthesia: general anesthesia (GA), continuous spinal anesthesia (CSA) and combined plexus blocks (CPB). The investigators therefore made three groups GA, CSA and CPB and used a propensity score to make these groups comparable. The matching criteria were age, arterial hypertension, ASA status, Frailty score, chronic cardiac failure and type of surgery.

Study Type

Observational

Enrollment (Actual)

593

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adults patients operated for hip fracture between 1 January 2015 and 31 December 2016.

Description

Inclusion criteria:

  • Adult
  • Hip fracture surgery

Exclusion criteria:

  • Multiple trauma victims
  • Second hip fracture in same patient
  • Single shot spinal 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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
General anaesthesia
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia
Observational study
continued spinal anesthesia
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia
Observational study
peripheral nerve blocks
Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks
Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative hypotension
Time Frame: 1 day
Decrease of at least 30% of mean arterial pressure
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure the total consumption of the vasopressive molecules
Time Frame: 1 day
measure the total consumption of the vasopressive molecules (necessary when the voltage drops by more than 30% compared to the average reference voltage) : Use of vasoactive drugs
1 day
Length of stay
Time Frame: 1 day
Length of stay
1 day
compare the use of emergency antalgics
Time Frame: 1 day
compare the use of emergency antalgics : opioids consumption
1 day
Inhospital mortality
Time Frame: 1 day
Inhospital mortality
1 day

Collaborators and Investigators

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

Investigators

  • Study Director: Xavier Capdevila, MD, PhD, University Hospital, Montpellier

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.

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)

August 31, 2016

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

October 26, 2017

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 28, 2017

First Posted (Actual)

November 29, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL17_0229

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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