Spinal AnesthesiaNCT06093412
Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
An observational study of Spinal Anesthesia, run by Sichuan Provincial People's Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 66 to 94 years
- Conditions the study is for
- Spinal Anesthesia
- What is being tested?
- unilateral epidural anesthesia and combined lumbar and epidural anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jun 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 66 to 94 years
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Spinal Anesthesia
- Being tested
- unilateral epidural anesthesia, combined lumbar and epidural anesthesia
- Keywords
- unilateral epidural anesthesia, combined lumbar and epidural anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral epidural anesthesiaProcedure or surgery
The patients received unilateral epidural anesthesia
combined lumbar and epidural anesthesiaProcedure or surgery
The patients received combined lumbar and epidural anesthesia
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: 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). Receives: Procedure: combined lumbar and epidural anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic change
Heart rate
Measured: Within 5 minutes after anesthesia
Hemodynamic change
Oxygen saturation
Measured: Within 5 minutes after anesthesia
Hemodynamic change
Heart rate
Measured: Within 10 minutes after anesthesia
Hemodynamic change
Oxygen saturation
Measured: Within 10 minutes after anesthesia
Hemodynamic change
Heart rate
Measured: Within 15 minutes after anesthesia
Hemodynamic change
Oxygen saturation
Measured: Within 15 minutes after anesthesia
Hemodynamic change
Heart rate
Measured: Within 20 minutes after anesthesia
Hemodynamic change
Oxygen saturation
Measured: Within 20 minutes after anesthesia
Secondary outcomes (1)
Dose of ephedrine use
Recoded dose of ephedrine use
Measured: During the surgery period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Liu, Sichuan Provincial People's Hospital
- Investigators
- Overall Study Officials Zhao, M.D., Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093412
- Sponsor's protocol ID
- h9mwa68d
- Status last verified
- Oct 2023
- First submitted
- 29 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25662415Cheng 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.
PubMed 21484361Bentler 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.
PubMed 19808632
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Unilateral Epidural Anesthesia in Older Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT06093412
- Acronym / sponsor ID
- h9mwa68d
- Conditions
- Spinal Anesthesia
- Keywords
- unilateral epidural anesthesia, combined lumbar and epidural anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral epidural anesthesia (UEA) group | – | Procedure: unilateral epidural anesthesiaPatients 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). |
| combined lumbar and epidural anesthesia (CSEA) group | – | Procedure: combined lumbar and epidural anesthesiaPatients 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). |
Who may qualify
- Ages
- 66 to 94 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| unilateral epidural anesthesiaThe patients received unilateral epidural anesthesia | Procedure or surgery | unilateral epidural anesthesia (UEA) group |
| combined lumbar and epidural anesthesiaThe patients received combined lumbar and epidural anesthesia | Procedure or surgery | combined lumbar and epidural anesthesia (CSEA) group |
Primary outcome
Hemodynamic change
Time frame: Within 5 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 5 minutes after anesthesia
Oxygen saturation
Hemodynamic change
Time frame: Within 10 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 10 minutes after anesthesia
Oxygen saturation
Hemodynamic change
Time frame: Within 15 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 15 minutes after anesthesia
Oxygen saturation
Hemodynamic change
Time frame: Within 20 minutes after anesthesia
Heart rate
Hemodynamic change
Time frame: Within 20 minutes after anesthesia
Oxygen saturation
1 secondary outcome
Dose of ephedrine use
Time frame: During the surgery period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Background: PubMed 25662415Prestmo 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.
- Background: PubMed 21484361Cheng 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.
- Background: PubMed 19808632Bentler 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.
- Individual participant dataSharing planned: No
Related trials for Spinal Anesthesia
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Active, not recruitingObservational study
The Effect of Magnesium on Post-spinal Headaches
Post-spinal Headache
Not yet recruitingPhase 4
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
Spinal Anaesthesia Induced Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Overall Study Officials Zhao, M.D. principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Anesthesia, run by Sichuan Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic change (time frame: Within 5 minutes after anesthesia). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093412, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.