Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures

Bursa Yuksek Ihtisas Training and Research Hospital

Status: Completed

Conditions: Femur Neck Fracture; Lumbar Plexus Nerve Block; Spinal Anesthesia

Treatments: Procedure: Hipobaric Unilateral Spinal Anesthesia Group; Procedure: Lumbar Plexus Block (LP-SP)

Study type: Interventional

Funder types: Other

Identifiers

NCT07272226

2011- KAEK-25 2023/07-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Hipobaric Unilateral Spinal Anesthesia Group

Experimental group

Treatment:

Procedure: Hipobaric Unilateral Spinal Anesthesia Group

Lomber Plexus Block Group

Experimental group

Treatment:

Procedure: Lumbar Plexus Block (LP-SP)