NCT03356704

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
593

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Status
completed

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

Study Start

First participant enrolled

August 31, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 29, 2017

Completed
Last Updated

July 19, 2018

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

October 26, 2017

Last Update Submit

July 17, 2018

Conditions

Keywords

adults

Outcome Measures

Primary Outcomes (1)

  • Intraoperative hypotension

    Decrease of at least 30% of mean arterial pressure

    1 day

Secondary Outcomes (4)

  • measure the total consumption of the vasopressive molecules

    1 day

  • Length of stay

    1 day

  • compare the use of emergency antalgics

    1 day

  • Inhospital mortality

    1 day

Study Arms (3)

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

Observational study

General anaesthesiacontinued spinal anesthesiaperipheral nerve blocks

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Adult
  • Hip fracture surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Xavier Capdevila, MD, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 29, 2017

Study Start

August 31, 2016

Primary Completion

February 1, 2017

Study Completion

October 26, 2017

Last Updated

July 19, 2018

Record last verified: 2017-10