Vergelijking van unilaterale spinale anesthesie en zenuwblokkade bij heupfracturen
Vergelijking van de effectiviteit van lumbale plexusblokkade en unilaterale hypobare spinale anesthesie bij patiënten die een operatie voor een femorale halsfractuur ondergaan
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Bursa, Turkije (Türkiye)
- Healt Science University Bursa Yuksek Ihtisas Research and Education Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Preoperative or intraoperative conversion to general anesthesia.
- Pregnant patients.
- Severe spinal deformities preventing regional anesthesia application.
- Refusal to participate in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Hipobarische Unilaterale Ruggenprikgroep
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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. |
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Experimenteel: Lumbale Plexus Blokkade Groep
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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State Entropy(SE)
Tijdsspanne: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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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. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
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Response Entropy(RE)
Tijdsspanne: 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. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Surgical Pleth Index (SPI)
Tijdsspanne: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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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 |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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Intraoperative Blood Pressure Changes
Tijdsspanne: Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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To monitor systolic, diastolic, and mean arterial blood pressure changes during surgery. |
Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]
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Sedative Drug Requirement
Tijdsspanne: Entire surgery duration
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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). |
Entire surgery duration
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Total Intravenous Fluid Volume
Tijdsspanne: Entire surgery duration
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Total volume of intravenous fluids administered intraoperatively. The cumulative fluid amount will be recorded in milliliters (mL) during the entire surgery duration. |
Entire surgery duration
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Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2011- KAEK-25 2023/07-14
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
The data will not be shared due to privacy and confidentiality concerns.
Informatie over medicijnen en apparaten, studiedocumenten
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