Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

Sponsor
Sichuan Provincial People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT06093412
Collaborator
(none)
106
1
41.9
2.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: unilateral epidural anesthesia
  • Procedure: combined lumbar and epidural anesthesia

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 Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
106 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
Actual Study Start Date :
Jan 1, 2018
Actual Primary Completion Date :
Jun 30, 2020
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm 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).

Procedure: unilateral epidural anesthesia
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).

Procedure: combined lumbar and epidural anesthesia
The patients received combined lumbar and epidural anesthesia

Outcome Measures

Primary Outcome Measures

  1. Hemodynamic change [Within 5 minutes after anesthesia]

    Heart rate

  2. Hemodynamic change [Within 5 minutes after anesthesia]

    Oxygen saturation

  3. Hemodynamic change [Within 10 minutes after anesthesia]

    Heart rate

  4. Hemodynamic change [Within 10 minutes after anesthesia]

    Oxygen saturation

  5. Hemodynamic change [Within 15 minutes after anesthesia]

    Heart rate

  6. Hemodynamic change [Within 15 minutes after anesthesia]

    Oxygen saturation

  7. Hemodynamic change [Within 20 minutes after anesthesia]

    Heart rate

  8. Hemodynamic change [Within 20 minutes after anesthesia]

    Oxygen saturation

Secondary Outcome Measures

  1. Dose of ephedrine use [During the surgery period]

    Recoded dose of ephedrine use

Other Outcome Measures

  1. Duration of hospital stay [During the surgery period]

    Recoded duration of hospital stay

  2. Mortality [Perioperative period]

    Mortality

  3. Lower limb function [One year later]

    Lower limb function (Harris score)

Eligibility Criteria

Criteria

Ages Eligible for Study:
66 Years to 94 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sichuan Provincial People's Hospital Chengdu Sichuan China 610072

Sponsors and Collaborators

  • Sichuan Provincial People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Peng Liu, Professor, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier:
NCT06093412
Other Study ID Numbers:
  • h9mwa68d
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peng Liu, Professor, Sichuan Provincial People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023