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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03356704
Other study ID # RECHMPL17_0229
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 31, 2016
Est. completion date October 26, 2017

Study information

Verified date October 2017
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 593
Est. completion date October 26, 2017
Est. primary completion date February 1, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria:

- Adult

- Hip fracture surgery

Exclusion criteria:

- Multiple trauma victims

- Second hip fracture in same patient

- Single shot spinal anesthesia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
Observational study

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative hypotension Decrease of at least 30% of mean arterial pressure 1 day
Secondary measure the total consumption of the vasopressive molecules 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
Secondary Length of stay Length of stay 1 day
Secondary compare the use of emergency antalgics compare the use of emergency antalgics : opioids consumption 1 day
Secondary Inhospital mortality Inhospital mortality 1 day
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