Clinical trial NCT06093412: Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
Official title: Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Anesthesia
Keywords: unilateral epidural anesthesia
combined lumbar and epidural anesthesia
Lead sponsor: Sichuan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 106
Sex: ALL
Minimum age (years): 66
Maximum age (years): 94
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hemodynamic change
timeFrame: Within 5 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 5 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 10 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 10 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 15 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 15 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 20 minutes after anesthesia
measure: Hemodynamic change
timeFrame: Within 20 minutes after anesthesia
Secondary outcomes:
measure: Dose of ephedrine use
timeFrame: During the surgery period
Other outcomes:
measure: Duration of hospital stay
timeFrame: During the surgery period
measure: Mortality
timeFrame: Perioperative period
measure: Lower limb function
timeFrame: One year later
Locations:
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
Study officials:
affiliation: Sichuan Provincial People's Hospital
name: Overall Study Officials Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.