- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sichuan
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Chengdu, Sichuan, China, 610072
- Sichuan Provincial People's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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).
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The patients received unilateral epidural anesthesia
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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).
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The patients received combined lumbar and epidural anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodynamic change
Time Frame: Within 5 minutes after anesthesia
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Heart rate
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Within 5 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 5 minutes after anesthesia
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Oxygen saturation
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Within 5 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 10 minutes after anesthesia
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Heart rate
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Within 10 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 10 minutes after anesthesia
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Oxygen saturation
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Within 10 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 15 minutes after anesthesia
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Heart rate
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Within 15 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 15 minutes after anesthesia
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Oxygen saturation
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Within 15 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 20 minutes after anesthesia
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Heart rate
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Within 20 minutes after anesthesia
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Hemodynamic change
Time Frame: Within 20 minutes after anesthesia
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Oxygen saturation
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Within 20 minutes after anesthesia
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose of ephedrine use
Time Frame: During the surgery period
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Recoded dose of ephedrine use
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During the surgery period
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of hospital stay
Time Frame: During the surgery period
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Recoded duration of hospital stay
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During the surgery period
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Mortality
Time Frame: Perioperative period
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Mortality
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Perioperative period
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Lower limb function
Time Frame: One year later
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Lower limb function (Harris score)
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One year later
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Collaborators and Investigators
Investigators
- Principal Investigator: Overall Study Officials Zhao, M.D., Sichuan Provincial People's Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- h9mwa68d
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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