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).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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

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

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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

University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Bursa

Other trials in Turkey (Türkiye)

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 groups in NCT07346885
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.

30 Dec 20251 Nov 2026

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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