Comparison of Unilateral Spinal Anesthesia and Nerve Block in Hip Fractures

NCT07272226 | Completed

• 1 other identifier: 2011- KAEK-25 2023/07-14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Femur Neck Fracture; Spinal Anesthesia; Lumbar Plexus Nerve Block

Keywords

Spinal Anesthesia; Lumbar Plexus Block; Femoral Neck Fracture; Regional Anesthesia; Peripheral Nerve Block

Outcome Measures

Primary Outcomes (2)

• State Entropy(SE)

  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]

• Response Entropy(RE)

  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]

Secondary Outcomes (4)

• Surgical Pleth Index (SPI)

  Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]

• Intraoperative Blood Pressure Changes

  Intraoperative period (baseline, 5, 15, 30, 45, 60, 90, and 120 minutes, and end of surgery [up to 3 hours]

• Sedative Drug Requirement

  Entire surgery duration

• Total Intravenous Fluid Volume

  Entire surgery duration

Study Arms (2)

Hipobaric Unilateral Spinal Anesthesia Group

EXPERIMENTAL

Procedure: Hipobaric Unilateral Spinal Anesthesia Group

Lomber Plexus Block Group

EXPERIMENTAL

Procedure: Lumbar Plexus Block (LP-SP)

Interventions

Hipobaric Unilateral Spinal Anesthesia Group 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.

Hipobaric Unilateral Spinal Anesthesia Group

Lumbar Plexus Block (LP-SP) 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.

Lomber Plexus Block Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Healt Science University Bursa Yuksek Ihtisas Research and Education Hospital

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Resident

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: December 9, 2025
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: December 15, 2024
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)