Femur Neck FractureNCT07272226
Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures
A study testing Hipobaric Unilateral Spinal Anesthesia Group and Lumbar Plexus Block (LP-SP) in people with Femur Neck Fracture and Spinal Anesthesia, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This randomized study aims to compare the efficacy and hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Femur Neck Fracture, Spinal Anesthesia, Lumbar Plexus Nerve Block
- What is being tested?
- Hipobaric Unilateral Spinal Anesthesia Group and Lumbar Plexus Block (LP-SP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 15 Dec 2024
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 90 years.
- American Society of Anesthesiologists (ASA) classification I-IV.
- Scheduled for femoral neck fracture surgery.
- Provided informed consent to participate in the study.
Who cannot join
- History of allergy to local anesthetics.
- Presence of coagulopathy or bleeding disorders.
- Mental health disorders impairing consent or cooperation.
- Allergy to medications used in the study protocol.
- Presence of infection at the block site.
- Body mass index (BMI) > 30.
Show all 10Show fewer
- Preoperative or intraoperative conversion to general anesthesia.
- Pregnant patients.
- Severe spinal deformities preventing regional anesthesia application.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Healt Science University Bursa Yuksek Ihtisas Research and Education Hospital
Bursa
About this study
Official title: Comparison of the Effectiveness of Lumbar Plexus Block and Hypobaric Unilateral Spinal Anesthesia in Patients Undergoing Femoral Neck Fracture Surgery
This randomized study aims to compare the efficacy and hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. Conducted at a single center, the study includes 60 patients aged 18 to 90, classified as ASA I-IV, and evaluates anesthesia methods' impact on intraoperative parameters, including blood pressure, sedation needs, and recovery outcomes. The findings will inform anesthetic strategy selection based on patient characteristics and surgical requirements.
Read the detailed description
This prospective, randomized, controlled study is designed to compare hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block combined with sacral plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. The study will be conducted at Bursa Yüksek İhtisas Training and Research Hospital and will include a total of 60 patients aged between 18 and 90 years with ASA physical status I-IV.
Eligible patients will be randomized into two groups: the HUSA group and the LP-SP group. In the HUSA group, unilateral spinal anesthesia will be performed using 5 mg of 0.5% bupivacaine diluted with distilled water to achieve a hypobaric solution. In the LP-SP group, lumbar plexus block and sacral plexus block will be performed using ultrasound-guided Shamrock or paramedian sagittal approaches with 0.5% bupivacaine.
Standard intraoperative monitoring will be applied to all patients, including electrocardiography, non-invasive blood pressure, pulse oximetry, and anesthesia depth monitoring with entropy and surgical pleth index. Intraoperative sedation, vasopressor use, and intravenous fluid administration will be managed according to institutional clinical protocols and patient needs.
Hemodynamic parameters, anesthesia depth indices, nociception indices, sedation requirements, and recovery-related parameters will be recorded intraoperatively at predefined time points. All data will be collected prospectively and analyzed to compare the two anesthetic techniques in terms of intraoperative stability and perioperative management requirements.
- Being tested
- Hipobaric Unilateral Spinal Anesthesia Group, Lumbar Plexus Block (LP-SP)
- Keywords
- Spinal Anesthesia, Lumbar Plexus Block, Femoral Neck Fracture, Regional Anesthesia, Peripheral Nerve Block
- 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.
Hipobaric Unilateral Spinal Anesthesia GroupProcedure or surgery
Patients in this group receive hypobaric unilateral spinal anesthesia (HUSA) using 5 mg of 0.5% bupivacaine diluted with 3 mL of distilled water. The injection is administered at the L4-L5 intervertebral space in the lateral position. Hemodynamic parameters, sensory block levels, and intraoperative requirements are monitored.
Lumbar Plexus Block (LP-SP)Procedure or surgery
Patients in this group undergo lumbar plexus block (LP-SP) using a Shamrock or paramedian sagittal ultrasound-guided approach. A mixture of 0.5% bupivacaine and saline (total volume: 25-35 mL) is administered based on patient body weight (max 2.5 mg/kg). Neurostimulation is used to confirm accurate needle placement in the psoas muscle. Hemodynamic stability, block efficacy, and sedation needs are assessed.
| Study group | Role | What they receive |
|---|---|---|
| Hipobaric Unilateral Spinal Anesthesia Group | Experimental | Not described Receives: Procedure: Hipobaric Unilateral Spinal Anesthesia Group |
| Lomber Plexus Block Group | Experimental | Not described Receives: Procedure: Lumbar Plexus Block (LP-SP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Entropy(SE)
To measure the depth of anesthesia using the State Entropy (SE) index during surgery. SE reflects cortical EEG activity and ranges from 0 to 91. Lower SE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery.
Measured: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Response Entropy(RE)
To measure the depth of anesthesia using the Response Entropy (RE) index during surgery. RE reflects combined cortical EEG and facial muscle activity and ranges from 0 to 100. Lower RE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery.
Measured: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Secondary outcomes (4)
Surgical Pleth Index (SPI)
To assess intraoperative nociception and stress levels using the Surgical Pleth Index (SPI). The SPI reflects autonomic responses to surgical stimuli and ranges from 0 to 100. Higher SPI values indicate higher nociception and stress. Measurements will be
Measured: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Intraoperative Blood Pressure Changes
To monitor systolic, diastolic, and mean arterial blood pressure changes during surgery.
Measured: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Sedative Drug Requirement
Total amount of sedative medications administered intraoperatively, including propofol and fentanyl. The cumulative dose will be recorded throughout the entire surgery duration (propofol in milligrams; fentanyl in micrograms).
Measured: Entire surgery duration
Total Intravenous Fluid Volume
Total volume of intravenous fluids administered intraoperatively. The cumulative fluid amount will be recorded in milliliters (mL) during the entire surgery duration.
Measured: Entire surgery duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start15 Sep 2023
- Primary completion15 Sep 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Neck FractureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokberk Kursat Ulker, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272226
- Sponsor's protocol ID
- 2011- KAEK-25 2023/07-14
- Status last verified
- Dec 2025
- First submitted
- 6 Jan 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared due to privacy and confidentiality concerns.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 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 Hypobaric Unilateral Spinal Anesthesia in Patients Undergoing Femoral Neck Fracture Surgery
- ClinicalTrials.gov ID
- NCT07272226
- Acronym / sponsor ID
- 2011- KAEK-25 2023/07-14
- Keywords
- Spinal Anesthesia, Lumbar Plexus Block, Femoral Neck Fracture, Regional Anesthesia, Peripheral Nerve Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 9 Dec 2025 (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.
This randomized study aims to compare the efficacy and hemodynamic effects of hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. Conducted at a single center, the study includes 60 patients aged 18 to 90, classified as ASA I-IV, and evaluates anesthesia methods' impact on intraoperative parameters, including blood pressure, sedation needs, and recovery outcomes. The findings will inform anesthetic strategy selection based on patient characteristics and surgical requirements.
Detailed description
This prospective, randomized, controlled study is designed to compare hypobaric unilateral spinal anesthesia (HUSA) and lumbar plexus block combined with sacral plexus block (LP-SP) in patients undergoing femoral neck fracture surgery. The study will be conducted at Bursa Yüksek İhtisas Training and Research Hospital and will include a total of 60 patients aged between 18 and 90 years with ASA physical status I-IV.
Eligible patients will be randomized into two groups: the HUSA group and the LP-SP group. In the HUSA group, unilateral spinal anesthesia will be performed using 5 mg of 0.5% bupivacaine diluted with distilled water to achieve a hypobaric solution. In the LP-SP group, lumbar plexus block and sacral plexus block will be performed using ultrasound-guided Shamrock or paramedian sagittal approaches with 0.5% bupivacaine.
Standard intraoperative monitoring will be applied to all patients, including electrocardiography, non-invasive blood pressure, pulse oximetry, and anesthesia depth monitoring with entropy and surgical pleth index. Intraoperative sedation, vasopressor use, and intravenous fluid administration will be managed according to institutional clinical protocols and patient needs.
Hemodynamic parameters, anesthesia depth indices, nociception indices, sedation requirements, and recovery-related parameters will be recorded intraoperatively at predefined time points. All data will be collected prospectively and analyzed to compare the two anesthetic techniques in terms of intraoperative stability and perioperative management requirements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hipobaric Unilateral Spinal Anesthesia Group | Experimental | Procedure: Hipobaric Unilateral Spinal Anesthesia Group |
| Lomber Plexus Block Group | Experimental | Procedure: Lumbar Plexus Block (LP-SP) |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 90 years.
- American Society of Anesthesiologists (ASA) classification I-IV.
- Scheduled for femoral neck fracture surgery.
- Provided informed consent to participate in the study.
Key exclusion criteria (10 listed)
- History of allergy to local anesthetics.
- Presence of coagulopathy or bleeding disorders.
- Mental health disorders impairing consent or cooperation.
- Allergy to medications used in the study protocol.
- Presence of infection at the block site.
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 |
|---|---|---|
| Hipobaric Unilateral Spinal Anesthesia GroupPatients in this group receive hypobaric unilateral spinal anesthesia (HUSA) using 5 mg of 0.5% bupivacaine diluted with 3 mL of distilled water. The injection is administered at the L4-L5 intervertebral space in the lateral position. Hemodynamic parameters, sensory block levels, and intraoperative requirements are monitored. | Procedure or surgery | Hipobaric Unilateral Spinal Anesthesia Group |
| Lumbar Plexus Block (LP-SP)Patients in this group undergo lumbar plexus block (LP-SP) using a Shamrock or paramedian sagittal ultrasound-guided approach. A mixture of 0.5% bupivacaine and saline (total volume: 25-35 mL) is administered based on patient body weight (max 2.5 mg/kg). Neurostimulation is used to confirm accurate needle placement in the psoas muscle. Hemodynamic stability, block efficacy, and sedation needs are assessed. | Procedure or surgery | Lomber Plexus Block Group |
Primary outcome
State Entropy(SE)
Time frame: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
To measure the depth of anesthesia using the State Entropy (SE) index during surgery. SE reflects cortical EEG activity and ranges from 0 to 91. Lower SE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery.
Response Entropy(RE)
Time frame: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
To measure the depth of anesthesia using the Response Entropy (RE) index during surgery. RE reflects combined cortical EEG and facial muscle activity and ranges from 0 to 100. Lower RE values indicate deeper levels of anesthesia. Measurements will be recorded intraoperatively at baseline and at 5, 15, 30, 45, 60, 90, and 120 minutes, as well as at the end of surgery.
4 secondary outcomes
Surgical Pleth Index (SPI)
Time frame: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Intraoperative Blood Pressure Changes
Time frame: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
Sedative Drug Requirement
Time frame: Entire surgery duration
Total Intravenous Fluid Volume
Time frame: Entire surgery duration
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 28 Sep 2026.
- Individual participant dataSharing planned: No. The data will not be shared due to privacy and confidentiality concerns.
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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 Hipobaric Unilateral Spinal Anesthesia Group and Lumbar Plexus Block (LP-SP) in people with Femur Neck Fracture and Spinal 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 4 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 28 Sep 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?
State Entropy(SE) (time frame: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]). The study lists 2 primary outcomes in all. 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 28 Sep 2026.