Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures

NCT ID: NCT07272226

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2024-12-15

Brief Summary

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.

Detailed 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.

Conditions

Femur Neck Fracture; Spinal Anesthesia; Lumbar Plexus Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Hipobaric Unilateral Spinal Anesthesia Group

Group Type: EXPERIMENTAL

Hipobaric Unilateral Spinal Anesthesia Group

Intervention Type: PROCEDURE

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.

Lomber Plexus Block Group

Group Type: EXPERIMENTAL

Lumbar Plexus Block (LP-SP)

Intervention Type: PROCEDURE

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.

Interventions

Hipobaric Unilateral Spinal Anesthesia Group

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.

Intervention Type: PROCEDURE

Lumbar Plexus Block (LP-SP)

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Gokberk Kursat Ulker

Anesthesiology and Reanimation Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Healt Science University Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2011- KAEK-25 2023/07-14

Identifier Type: -

Identifier Source: org_study_id