Femoral Neck FracturesNCT06224439
Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery
A study testing hypobaric spinal anaesthesia, lumbar plexus block and hyperbaric spinal anesthesia in people with Femoral Neck Fractures and Regional Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Femoral Neck Fractures, Regional Anesthesia
- What is being tested?
- hypobaric spinal anaesthesia, lumbar plexus block and hyperbaric spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2024to 13 Apr 2025
- Phase
- Interventional
- 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 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >60 years and <90 years
- ASA (American Society of Anesthesiologists) score between I and IV
- Patients who will undergo femoral neck fracture surgery
Who cannot join
- Previous local anesthetic allergy
- Those with bleeding diathesis disorder
- Having a mental disorder
- Those who are allergic to the drugs used
- Patients who did not consent to participate in the study
- Presence of infection in the block area
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- Body mass index >30
- Preoperative or intraoperative general anesthesia
- Patients for whom consent cannot be obtained
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110
About this study
Official title: Comparison of the Effectiveness of Lumbar Plexus Block and Unilateral Spinal Anaesthesia in Patients Undergoing Femoral Neck Fracture Surgery
Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.
Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.
Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.
- Conditions
- Femoral Neck Fractures, Regional Anesthesia
- Being tested
- hypobaric spinal anaesthesia, lumbar plexus block, hyperbaric spinal anesthesia
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypobaric spinal anaesthesiaProcedure or surgery
0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied .
lumbar plexus blockProcedure or surgery
ultrasound and nerve stimulator will be used for lumbar plexus block
hyperbaric spinal anesthesiaProcedure or surgery
0.5% hyperbaric Bupivacain hydrochloride active ingredient will be applied .
| Study group | Role | What they receive |
|---|---|---|
| hypobaric spinal anaesthesia | Active comparator | A 25 gauge Quincke needle will be used for spinal anesthesia. After positioning the patient on the side to be operated on, an incision will be made in the appropriate space (L3-4 or L4-5) to administer hypobaric spinal anesthesia. Once a feeling of falling is obtained in the subdural region, the flow of cerebrospinal fluid will be observed, and a solution of 0.5% bupivacaine and distilled water, containing the active ingredient bupivacaine hydrochloride, will be administered. Receives: Procedure: hypobaric spinal anaesthesia |
| lumbar plexus block | Active comparator | A 10-15 cm peripheral block needle, ultrasound and nerve stimulator will be used for lumbar plexus block. Buvicaine with 0.5% Bupivacaine Hydrochloride active substance will be used. It will be diluted half and half with saline. It will be applied in accordance with the patient's height and weight. Receives: Procedure: lumbar plexus block |
| hyperbaric spinal anaesthesia | Active comparator | 25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% hyper Bupivacain hydrochloride active ingredient will be applied . Receives: Procedure: hyperbaric spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative haemodynamic parameters
non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)
Measured: intraoperative 2 hours
Secondary outcomes (4)
Entropy
Entropy monitoring involves using electroencephalography-a strip of electrodes applied to the forehead-to assess the depth of general anesthesia in surgical patients. The goal of entropy monitoring is to ensure that patients are given appropriate levels of anesthesia so that recovery is faster. Entropy monitoring provides quantitative measurement of depth of anaesthesia. The Response Entropy scale ranges from 0 (no brain activity) to 100 (fully awake) and the State Entropy scale ranges from 0 (no brain activity) to 91 (fully awake). The clinically relevant target range for entropy values is 40-60.
Measured: intraoperative 2 hours
SPI
The surgical pleth index (SPI) is a dimensionless score which is based on the photoplethysmographic analysis of the pulse wave and the heart beat interval. SPI scores monitored during surgery may reflect a patient's autonomic response to certain nociceptive stimuli. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended
Measured: intraoperative 2 hours
sedation and analgesic
Intraoperative sedation and analgesic need (Whether there was a need or not how much is given in total mg or mcg)
Measured: intraoperative 2 hours
Intraoperative bleeding
Measured: intraoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start25 Jan 2024
- Primary completion1 Apr 2025
- Study completion13 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224439
- Sponsor's protocol ID
- 2023-5/15
- Status last verified
- Aug 2026
- First submitted
- 16 Jan 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Lumbar Plexus Block and Unilateral Spinal Anaesthesia in Patients Undergoing Femoral Neck Fracture Surgery
- ClinicalTrials.gov ID
- NCT06224439
- Acronym / sponsor ID
- 2023-5/15
- Conditions
- Femoral Neck Fractures, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 13 Apr 2025 (actual)
- First posted
- 25 Jan 2024 (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.
Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.
Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.
Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hypobaric spinal anaesthesia | Active comparator | Procedure: hypobaric spinal anaesthesiaA 25 gauge Quincke needle will be used for spinal anesthesia. After positioning the patient on the side to be operated on, an incision will be made in the appropriate space (L3-4 or L4-5) to administer hypobaric spinal anesthesia. Once a feeling of falling is obtained in the subdural region, the flow of cerebrospinal fluid will be observed, and a solution of 0.5% bupivacaine and distilled water, containing the active ingredient bupivacaine hydrochloride, will be administered. |
| lumbar plexus block | Active comparator | Procedure: lumbar plexus blockA 10-15 cm peripheral block needle, ultrasound and nerve stimulator will be used for lumbar plexus block. Buvicaine with 0.5% Bupivacaine Hydrochloride active substance will be used. It will be diluted half and half with saline. It will be applied in accordance with the patient's height and weight. |
| hyperbaric spinal anaesthesia | Active comparator | Procedure: hyperbaric spinal anesthesia25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% hyper Bupivacain hydrochloride active ingredient will be applied . |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >60 years and <90 years
- ASA (American Society of Anesthesiologists) score between I and IV
- Patients who will undergo femoral neck fracture surgery
Key exclusion criteria (10 listed)
- Previous local anesthetic allergy
- Those with bleeding diathesis disorder
- Having a mental disorder
- Those who are allergic to the drugs used
- Patients who did not consent to participate in the study
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 |
|---|---|---|
| hypobaric spinal anaesthesia0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied . | Procedure or surgery | hypobaric spinal anaesthesia |
| lumbar plexus blockultrasound and nerve stimulator will be used for lumbar plexus block | Procedure or surgery | lumbar plexus block |
| hyperbaric spinal anesthesia0.5% hyperbaric Bupivacain hydrochloride active ingredient will be applied . | Procedure or surgery | hyperbaric spinal anaesthesia |
Primary outcome
intraoperative haemodynamic parameters
Time frame: intraoperative 2 hours
non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)
4 secondary outcomes
Entropy
Time frame: intraoperative 2 hours
SPI
Time frame: intraoperative 2 hours
sedation and analgesic
Time frame: intraoperative 2 hours
Intraoperative bleeding
Time frame: intraoperative 2 hours
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 7 Aug 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypobaric spinal anaesthesia, lumbar plexus block and hyperbaric spinal anesthesia in people with Femoral Neck Fractures and Regional Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 10 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 7 Aug 2026. 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 Turkey (Türkiye). 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?
intraoperative haemodynamic parameters (time frame: intraoperative 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.