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Completed

NCT Number: NCT06093412

Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

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.

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Key information

Conditions

Age range

66 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

unilateral epidural anesthesia

Procedure

The patients received unilateral epidural anesthesia

combined lumbar and epidural anesthesia

Procedure

The patients received combined lumbar and epidural anesthesia

Primary outcomes

  1. Hemodynamic change

    Time frame: Within 5 minutes after anesthesia

    Heart rate

  2. Hemodynamic change

    Time frame: Within 5 minutes after anesthesia

    Oxygen saturation

  3. Hemodynamic change

    Time frame: Within 10 minutes after anesthesia

    Heart rate

  4. Hemodynamic change

    Time frame: Within 10 minutes after anesthesia

    Oxygen saturation

  5. Hemodynamic change

    Time frame: Within 15 minutes after anesthesia

    Heart rate

  6. Hemodynamic change

    Time frame: Within 15 minutes after anesthesia

    Oxygen saturation

  7. Hemodynamic change

    Time frame: Within 20 minutes after anesthesia

    Heart rate

  8. Hemodynamic change

    Time frame: Within 20 minutes after anesthesia

    Oxygen saturation

Secondary outcomes

  1. Dose of ephedrine use

    Time frame: During the surgery period

    Recoded dose of ephedrine use

Other outcomes

  1. Duration of hospital stay

    Time frame: During the surgery period

    Recoded duration of hospital stay

  2. Mortality

    Time frame: Perioperative period

    Mortality

  3. Lower limb function

    Time frame: One year later

    Lower limb function (Harris score)

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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