NCT06093412

Brief Summary

Because of population ageing, fragility fractures have become a huge burden on healthcare systems and wider society. Fractures result in a sharp drop in both short-term and long-term quality of life, they have a strong influence on activities of daily living and mobility, and they are associated with a significant increase in 1-year mortality (18%-36%). Surgery can benefit elderly patients with hip fractures to an extent, but it entails inevitable risks, particularly with respect to general anesthesia. In recent years unilateral spinal anesthesia has attracted attention due to the advantages of hemodynamic stability, reduced anesthetic dosage, and sufficient sensory block. On the basis of a previous study, in the current study anesthetics were directly implanted into the unilateral epidural space in elderly patients with hip fractures prior to the completion of surgery. Data from 106 patients with old hip fractures who had undergone surgical treatment incorporating unilateral epidural anesthesia (UEA) or combined lumbar and epidural anesthesia were retrospectively analyzed in an attempt to provide a feasible solution for this kind of patients' anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

January 1, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

2.5 years

First QC Date

September 29, 2023

Last Update Submit

October 16, 2023

Conditions

Spinal Anesthesia

Keywords

unilateral epidural anesthesiacombined lumbar and epidural anesthesia

Outcome Measures

Primary Outcomes (8)

  • Hemodynamic change

    Heart rate

    Within 5 minutes after anesthesia

  • Hemodynamic change

    Oxygen saturation

    Within 5 minutes after anesthesia

  • Hemodynamic change

    Heart rate

    Within 10 minutes after anesthesia

  • Hemodynamic change

    Oxygen saturation

    Within 10 minutes after anesthesia

  • Hemodynamic change

    Heart rate

    Within 15 minutes after anesthesia

  • Hemodynamic change

    Oxygen saturation

    Within 15 minutes after anesthesia

  • Hemodynamic change

    Heart rate

    Within 20 minutes after anesthesia

  • Hemodynamic change

    Oxygen saturation

    Within 20 minutes after anesthesia

Secondary Outcomes (1)

  • Dose of ephedrine use

    During the surgery period

Other Outcomes (3)

  • Duration of hospital stay

    During the surgery period

  • Mortality

    Perioperative period

  • Lower limb function

    One year later

Study Arms (2)

unilateral epidural anesthesia (UEA) group

Patients were divided into two groups based on the type of anesthesia they received; a UEA group (n = 42) and a combined spinal epidural anesthesia (CSEA) group (n = 64).

Procedure: unilateral epidural anesthesia

combined lumbar and epidural anesthesia (CSEA) group

Patients were divided into two groups based on the type of anesthesia they received; a UEA group (n = 42) and a combined spinal epidural anesthesia (CSEA) group (n = 64).

Procedure: combined lumbar and epidural anesthesia

Interventions

unilateral epidural anesthesiaPROCEDURE

The patients received unilateral epidural anesthesia

unilateral epidural anesthesia (UEA) group
combined lumbar and epidural anesthesiaPROCEDURE

The patients received combined lumbar and epidural anesthesia

combined lumbar and epidural anesthesia (CSEA) group

Eligibility Criteria

Age66 Years - 94 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The totally 106 older patients (49 male, 57 female) aged 65-94 years with hip fractures who underwent surgery between January 2018 and June 2020 at the Orthopedic Department of our Hospital.

You may qualify if:

  • had a fracture of a proximal femur were aged \> 65 years the fracture occurred within 2 weeks of receiving treatment with comorbidities including pulmonary disease, arrhythmia, senile valve disease or lacunar infarction underwent intraspinal anesthesia during surgery

You may not qualify if:

  • had a secondary fracture after endoprosthetic reconstruction or intramedullary nail had a pathological fracture caused by tumor or tuberculosis condition was accompanied by lower limb nerve dysfunction had a cognitive or psychiatric disorder coagulation disorders hospitalization data were incomplete.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Related Publications (3)

  • Prestmo A, Hagen G, Sletvold O, Helbostad JL, Thingstad P, Taraldsen K, Lydersen S, Halsteinli V, Saltnes T, Lamb SE, Johnsen LG, Saltvedt I. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial. Lancet. 2015 Apr 25;385(9978):1623-33. doi: 10.1016/S0140-6736(14)62409-0. Epub 2015 Feb 5.

    PMID: 25662415BACKGROUND

  • Cheng SY, Levy AR, Lefaivre KA, Guy P, Kuramoto L, Sobolev B. Geographic trends in incidence of hip fractures: a comprehensive literature review. Osteoporos Int. 2011 Oct;22(10):2575-86. doi: 10.1007/s00198-011-1596-z. Epub 2011 Apr 12.

    PMID: 21484361BACKGROUND

  • Bentler SE, Liu L, Obrizan M, Cook EA, Wright KB, Geweke JF, Chrischilles EA, Pavlik CE, Wallace RB, Ohsfeldt RL, Jones MP, Rosenthal GE, Wolinsky FD. The aftermath of hip fracture: discharge placement, functional status change, and mortality. Am J Epidemiol. 2009 Nov 15;170(10):1290-9. doi: 10.1093/aje/kwp266. Epub 2009 Oct 4.

    PMID: 19808632BACKGROUND

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Overall Study Officials Zhao, M.D.

    Sichuan Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 23, 2023

Study Start

January 1, 2018

Primary Completion

June 30, 2020

Study Completion

June 30, 2021

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)