Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

Spinal Anesthesia Clinical Trial

Official title:

Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06093412
• Other study ID #: h9mwa68d
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2023
• Source: Sichuan Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years to 94 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hip Fractures
• Spinal Anesthesia

Intervention

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

Locations

Country	Name	City	State
China	Sichuan Provincial People's Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of hospital stay	Recoded duration of hospital stay	During the surgery period
Other	Mortality	Mortality	Perioperative period
Other	Lower limb function	Lower limb function (Harris score)	One year later
Primary	Hemodynamic change	Heart rate	Within 5 minutes after anesthesia
Primary	Hemodynamic change	Oxygen saturation	Within 5 minutes after anesthesia
Primary	Hemodynamic change	Heart rate	Within 10 minutes after anesthesia
Primary	Hemodynamic change	Oxygen saturation	Within 10 minutes after anesthesia
Primary	Hemodynamic change	Heart rate	Within 15 minutes after anesthesia
Primary	Hemodynamic change	Oxygen saturation	Within 15 minutes after anesthesia
Primary	Hemodynamic change	Heart rate	Within 20 minutes after anesthesia
Primary	Hemodynamic change	Oxygen saturation	Within 20 minutes after anesthesia
Secondary	Dose of ephedrine use	Recoded dose of ephedrine use	During the surgery period