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CompletedNCT03356704Updated Jul 19, 2018

Combined Plexus Block for Hip Fracture Surgery.

An observational study in Hip Fractures, sponsored by University Hospital, Montpellier. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-19.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
593
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hip Fractures

Keywords

  • adults
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Inclusion criteria

  • Adult
  • Hip fracture surgery

Exclusion criteria

Exclusion criteria:

  • Multiple trauma victims
  • Second hip fracture in same patient
  • Single shot spinal anesthesia
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
593 participants (actual)
Patient registry
No

Groups and cohorts

  • General anaesthesia

    Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had general anesthesia

    Other: no intervention

  • continued spinal anesthesia

    Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had continued spinal anesthesia

    Other: no intervention

  • peripheral nerve blocks

    Patient who had surgery for femoral neck fracture from January 2014 to December 2016 and had peripheral nerve blocks

    Other: no intervention

Interventions

  • Otherno intervention

    Observational study

05

What researchers measure

Primary outcomes

  1. Intraoperative hypotension

    Decrease of at least 30% of mean arterial pressure

    Time frame: 1 day

Secondary outcomes

  1. 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

    Time frame: 1 day

  2. Length of stay

    Length of stay

    Time frame: 1 day

  3. compare the use of emergency antalgics

    compare the use of emergency antalgics : opioids consumption

    Time frame: 1 day

  4. Inhospital mortality

    Inhospital mortality

    Time frame: 1 day

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Mounet B, Choquet O, Swisser F, Biboulet P, Bernard N, Bringuier S, Capdevila X. Impact of multiple nerves blocks anaesthesia on intraoperative hypotension and mortality in hip fracture surgery intermediate-risk elderly patients: A propensity score-matched comparison with spinal and general anaesthesia. Anaesth Crit Care Pain Med. 2021 Aug;40(4):100924. doi: 10.1016/j.accpm.2021.100924. Epub 2021 Jul 1. PubMed 34217841 ↗

Individual participant data

Plan to share: Undecided — NC

08

Registry details

Key details

Study ID
NCT03356704
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Nov 29, 2017
Start date
Aug 31, 2016
Primary completion
Feb 1, 2017
Completion
Oct 26, 2017
Last update
Jul 19, 2018

Study contacts

Xavier Capdevila, MD, PhD
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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