- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346885
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
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
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Bursa, Turkey (Türkiye)
- University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
->18 years and <90 years
- American Society of Anesthesiologists score between I and IV
- Patients who will undergo femoral neck fracture surgery
Exclusion Criteria:
- 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
- Body mass index >30
- Preoperative or intraoperative general anesthesia
- Patients for whom consent cannot be obtained
- Pregnant patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Lumbar and Sacral Plexus Block Group
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.
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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.
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Active Comparator: Fascia Iliaca Block Combined with Low-Dose Spinal Anesthesia Group
Patients will receive low-dose spinal anesthesia combined with a supra-inguinal fascia iliaca block for surgical anesthesia and postoperative analgesia.
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of Severe Intraoperative Hypotension
Time Frame: Intraoperative period
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Severe hypotension defined as mean arterial pressure (MAP) < 65 mmHg lasting longer than 12 minutes during surgery
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Intraoperative period
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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intraoperative haemodynamic parameters
Time Frame: intraoperative 2 hours
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non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg) |
intraoperative 2 hours
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Total Intraoperative Sedative and Analgesic Drug Consumption
Time Frame: intraoperative 2 hours
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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.
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intraoperative 2 hours
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Estimated Intraoperative Blood Loss (mL)
Time Frame: intraoperative 2 hours
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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.
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intraoperative 2 hours
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Postoperative Pain Intensity Assessed by the Numeric Rating Scale (NRS)
Time Frame: postoperative 24 hour
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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
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postoperative 24 hour
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Intraoperative Vasopressor Consumption
Time Frame: Intraoperative period
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Total dose of vasopressors administered
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Intraoperative period
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Length of Hospital Stay (days)
Time Frame: From the day of surgery through hospital discharge (up to 30 days)
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Length of hospital stay will be defined as the number of days from the day of surgery until hospital discharge.
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From the day of surgery through hospital discharge (up to 30 days)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BursaYIEAH-2024 TBEK 2025/12-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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