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NCT Number: NCT06224439

Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

Femoral fracture surgery is frequently performed especially in geriatric population. Compared to general anaesthesia, regional anaesthesia is preferred to general anaesthesia in the geriatric patient population due to lower postoperative pulmonary complications, reduced frequency of delirium and analgesic requirement, intraoperative haemodynamic stability, early postoperative mobilisation and early discharge.

Central and peripheral regional anaesthesia methods have advantages and disadvantages. This situation causes difficulties in the choice of anaesthesia method. Central regional anaesthesia techniques have more haemodynamic effects and higher frequency of complications compared to peripheral methods. The disadvantages of peripheral methods are that they require ultrasound, block needle, nerve stimulator and require knowledgeable and skilled practitioners.

Since there is no study showing the comparison of peripheral nerve blocks and hypobaric spinal anaesthesia with objective nociception values and there are difficulties in the choice of anaesthesia method in this regard, a study was deemed necessary.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Regional Anesthesia Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >18 years and <90 years
  • ASA (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

Treatment and study plan

hypobaric spinal anaesthesia

Procedure

0.5% Bupivacain and distilled water with bupivacaine hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

lumbar plexus block

Procedure

ultrasound and nerve stimulator will be used for lumbar plexus block

hyperbaric spinal anesthesia

Procedure

0.5% hyperbaric Bupivacain hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Primary outcomes

  1. intraoperative haemodynamic parameters

    Time frame: intraoperative 2 hours

    non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)

Secondary outcomes

  1. Entropy

    Time frame: intraoperative 2 hours

    Entropy monitoring involves using electroencephalography-a strip of electrodes applied to the forehead-to assess the depth of general anesthesia in surgical patients. The goal of entropy monitoring is to ensure that patients are given appropriate levels of anesthesia so that recovery is faster. Entropy monitoring provides quantitative measurement of depth of anaesthesia. The Response Entropy scale ranges from 0 (no brain activity) to 100 (fully awake) and the State Entropy scale ranges from 0 (no brain activity) to 91 (fully awake). The clinically relevant target range for entropy values is 40-60.

  2. SPI

    Time frame: intraoperative 2 hours

    The surgical pleth index (SPI) is a dimensionless score which is based on the photoplethysmographic analysis of the pulse wave and the heart beat interval. SPI scores monitored during surgery may reflect a patient's autonomic response to certain nociceptive stimuli. The values of the SPI range from 0 to 100. During general anaesthesia, maintaining a value between 20 and 50 is generally recommended

  3. sedation and analgesic

    Time frame: intraoperative 2 hours

    Intraoperative sedation and analgesic need (Whether there was a need or not how much is given in total mg or mcg)

  4. Intraoperative bleeding

    Time frame: intraoperative 2 hours

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effectiveness of Lumbar Plexus Block and Unilateral Spinal Anaesthesia in Patients Undergoing Femoral Neck Fracture Surgery

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 25, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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