Femoral Neck FracturesNCT07346885
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
A study testing Lumbar and Sacral Plexus Block and Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia in people with Femoral Neck Fractures and Nerve Block, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Femoral neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femoral Neck Fractures, Nerve Block
- What is being tested?
- Lumbar and Sacral Plexus Block and Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ->18 years and <90 years
- 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
Show all 10Show fewer
- 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
University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Bursa
About this study
Official title: A Comparison of the Efficacy of Lumbar and Sacral Plexus Block Versus Fascia Iliaca Block Combined With Low-Dose Spinal Anesthesia in Patients Undergoing Surgery for a Femoral Neck Fracture
Femoral neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. This prospective observational study aims to compare the efficacy of lumbar and sacral plexus block with fascia iliaca block combined with low-dose spinal anesthesia in terms of severe intraoperative hypotension and postoperative analgesic outcomes in patients undergoing surgery for femoral neck fracture.
Read the detailed description
The global incidence of hip fractures continues to rise, and most patients require surgical intervention. Due to advanced age, frailty, and multiple comorbidities, anesthetic management in this population is particularly challenging. Intraoperative hypotension has been shown to be associated with increased short- and long-term mortality, regardless of the anesthetic technique used.
To reduce the incidence of hypotension, various neuraxial and peripheral nerve block techniques have been investigated. While spinal anesthesia provides reliable surgical conditions, it may still cause significant hypotension. Peripheral nerve blocks, such as lumbar and sacral plexus blocks or fascia iliaca block, tend to preserve hemodynamic stability and are associated with a lower incidence of motor blockade.
Recently, combined techniques using low-dose spinal anesthesia together with fascial plane blocks have been introduced to balance the advantages of neuraxial anesthesia and peripheral nerve blocks. However, there is still no consensus on the optimal regional anesthesia strategy to minimize severe hypotension while ensuring effective analgesia in patients undergoing femoral neck fracture surgery.
- Conditions
- Femoral Neck Fractures, Nerve Block
- Being tested
- Lumbar and Sacral Plexus Block, Fascia Iliaca Block Combined with Low-Dose 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.
Lumbar and Sacral Plexus BlockProcedure or surgery
For lumbar and sacral plexus blocks, a 10-15 cm ultrasound-visible peripheral nerve block needle and a nerve stimulator will be used. For lumbar plexus shamrock imaging and sacral plexus blocks, parasacral imaging will be used. 0.5% bupivacaine will be used as the local anesthetic.
Fascia Iliaca Block Combined with Low-Dose Spinal AnesthesiaProcedure or surgery
Spinal anesthesia will be administered using a 25-gauge Quincke needle. After positioning the patient on the side to be operated on in a lateral position, hypobaric spinal anesthesia will be administered through an appropriate (L3-4 or L4-5) with 1.5 cc of local anesthetic mixture. Before receiving spinal anesthesia, patients will undergo a supra-inguinal fascia iliaca block with 20 to 30 milliliters of 0.25% local anesthetic (bupivacaine).
| Study group | Role | What they receive |
|---|---|---|
| Lumbar and Sacral Plexus Block Group | Active comparator | Patients will receive combined lumbar and sacral plexus blocks as the primary regional anesthesia technique for femoral neck fracture surgery, performed by the attending anesthesiologist according to institutional practice. Receives: Procedure: Lumbar and Sacral Plexus Block |
| Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group | Active comparator | Patients will receive low-dose spinal anesthesia combined with a supra-inguinal fascia iliaca block for surgical anesthesia and postoperative analgesia. Receives: Procedure: Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Severe Intraoperative Hypotension
Severe hypotension defined as mean arterial pressure (MAP) < 65 mmHg lasting longer than 12 minutes during surgery
Measured: Intraoperative period
Secondary outcomes (6)
intraoperative haemodynamic parameters
non-invasive systolic, diastolic and mean arterial pressure
mean arterial pressure (mm/hg)
Measured: intraoperative 2 hours
Total Intraoperative Sedative and Analgesic Drug Consumption
Total intraoperative sedative and analgesic drug consumption will be recorded, including the cumulative dose of sedative agents (e.g., propofol, midazolam) and analgesic agents (e.g., fentanyl or equivalent opioids) administered during surgery.
Measured: intraoperative 2 hours
Estimated Intraoperative Blood Loss (mL)
Estimated intraoperative blood loss will be assessed by the anesthesiology team based on suction canister volume minus irrigation fluids and surgical sponge weight estimation, as routinely used in clinical practice.
Measured: intraoperative 2 hours
Postoperative Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be recorded at rest and during movement
Measured: postoperative 24 hour
Intraoperative Vasopressor Consumption
Total dose of vasopressors administered
Measured: Intraoperative period
Length of Hospital Stay (days)
Length of hospital stay will be defined as the number of days from the day of surgery until hospital discharge.
Measured: From the day of surgery through hospital discharge (up to 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start30 Dec 2025
- Primary completion1 Jul 2026
- Study completion1 Nov 2026 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
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
- NCT07346885
- Sponsor's protocol ID
- TBEK 2025/12-14
- Status last verified
- Oct 2026
- First submitted
- 29 Dec 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy of Lumbar and Sacral Plexus Block Versus Fascia Iliaca Block Combined With Low-Dose Spinal Anesthesia in Patients Undergoing Surgery for a Femoral Neck Fracture
- ClinicalTrials.gov ID
- NCT07346885
- Acronym / sponsor ID
- TBEK 2025/12-14
- Conditions
- Femoral Neck Fractures, Nerve Block
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Jan 2026 (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 neck fracture surgery in elderly patients is frequently complicated by intraoperative hypotension and inadequate postoperative analgesia. Regional anesthesia techniques are increasingly preferred to reduce hemodynamic instability and improve pain control. This prospective observational study aims to compare the efficacy of lumbar and sacral plexus block with fascia iliaca block combined with low-dose spinal anesthesia in terms of severe intraoperative hypotension and postoperative analgesic outcomes in patients undergoing surgery for femoral neck fracture.
Detailed description
The global incidence of hip fractures continues to rise, and most patients require surgical intervention. Due to advanced age, frailty, and multiple comorbidities, anesthetic management in this population is particularly challenging. Intraoperative hypotension has been shown to be associated with increased short- and long-term mortality, regardless of the anesthetic technique used.
To reduce the incidence of hypotension, various neuraxial and peripheral nerve block techniques have been investigated. While spinal anesthesia provides reliable surgical conditions, it may still cause significant hypotension. Peripheral nerve blocks, such as lumbar and sacral plexus blocks or fascia iliaca block, tend to preserve hemodynamic stability and are associated with a lower incidence of motor blockade.
Recently, combined techniques using low-dose spinal anesthesia together with fascial plane blocks have been introduced to balance the advantages of neuraxial anesthesia and peripheral nerve blocks. However, there is still no consensus on the optimal regional anesthesia strategy to minimize severe hypotension while ensuring effective analgesia in patients undergoing femoral neck fracture surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar and Sacral Plexus Block Group | Active comparator | Procedure: Lumbar and Sacral Plexus BlockPatients will receive combined lumbar and sacral plexus blocks as the primary regional anesthesia technique for femoral neck fracture surgery, performed by the attending anesthesiologist according to institutional practice. |
| Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group | Active comparator | Procedure: Fascia Iliaca Block Combined with Low-Dose Spinal AnesthesiaPatients will receive low-dose spinal anesthesia combined with a supra-inguinal fascia iliaca block for surgical anesthesia and postoperative analgesia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ->18 years and <90 years
- 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 |
|---|---|---|
| Lumbar and Sacral Plexus BlockFor lumbar and sacral plexus blocks, a 10-15 cm ultrasound-visible peripheral nerve block needle and a nerve stimulator will be used. For lumbar plexus shamrock imaging and sacral plexus blocks, parasacral imaging will be used. 0.5% bupivacaine will be used as the local anesthetic. | Procedure or surgery | Lumbar and Sacral Plexus Block Group |
| Fascia Iliaca Block Combined with Low-Dose Spinal AnesthesiaSpinal anesthesia will be administered using a 25-gauge Quincke needle. After positioning the patient on the side to be operated on in a lateral position, hypobaric spinal anesthesia will be administered through an appropriate (L3-4 or L4-5) with 1.5 cc of local anesthetic mixture. Before receiving spinal anesthesia, patients will undergo a supra-inguinal fascia iliaca block with 20 to 30 milliliters of 0.25% local anesthetic (bupivacaine). | Procedure or surgery | Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group |
Primary outcome
Incidence of Severe Intraoperative Hypotension
Time frame: Intraoperative period
Severe hypotension defined as mean arterial pressure (MAP) < 65 mmHg lasting longer than 12 minutes during surgery
6 secondary outcomes
intraoperative haemodynamic parameters
Time frame: intraoperative 2 hours
Total Intraoperative Sedative and Analgesic Drug Consumption
Time frame: intraoperative 2 hours
Estimated Intraoperative Blood Loss (mL)
Time frame: intraoperative 2 hours
Postoperative Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Time frame: postoperative 24 hour
Intraoperative Vasopressor Consumption
Time frame: Intraoperative period
Length of Hospital Stay (days)
Time frame: From the day of surgery through hospital discharge (up to 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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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 Lumbar and Sacral Plexus Block and Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia in people with Femoral Neck Fractures and Nerve Block, 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: under way, not looking for participants, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Severe Intraoperative Hypotension (time frame: Intraoperative period). 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 14 Oct 2026.