Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

October 16, 2023 updated by: Peng Liu, Sichuan Provincial People's Hospital

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
The patients received 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).
The patients received combined lumbar and epidural anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic change
Time Frame: Within 5 minutes after anesthesia
Heart rate
Within 5 minutes after anesthesia
Hemodynamic change
Time Frame: Within 5 minutes after anesthesia
Oxygen saturation
Within 5 minutes after anesthesia
Hemodynamic change
Time Frame: Within 10 minutes after anesthesia
Heart rate
Within 10 minutes after anesthesia
Hemodynamic change
Time Frame: Within 10 minutes after anesthesia
Oxygen saturation
Within 10 minutes after anesthesia
Hemodynamic change
Time Frame: Within 15 minutes after anesthesia
Heart rate
Within 15 minutes after anesthesia
Hemodynamic change
Time Frame: Within 15 minutes after anesthesia
Oxygen saturation
Within 15 minutes after anesthesia
Hemodynamic change
Time Frame: Within 20 minutes after anesthesia
Heart rate
Within 20 minutes after anesthesia
Hemodynamic change
Time Frame: Within 20 minutes after anesthesia
Oxygen saturation
Within 20 minutes after anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of ephedrine use
Time Frame: During the surgery period
Recoded dose of ephedrine use
During the surgery period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of hospital stay
Time Frame: During the surgery period
Recoded duration of hospital stay
During the surgery period
Mortality
Time Frame: Perioperative period
Mortality
Perioperative period
Lower limb function
Time Frame: One year later
Lower limb function (Harris score)
One year later

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Overall Study Officials Zhao, M.D., Sichuan Provincial People's Hospital

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)

January 1, 2018

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 16, 2023

First Posted (Actual)

October 23, 2023

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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