Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

NCT06224439 | Completed

• 1 other identifier: 2023-5/15
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Femoral Neck Fractures; Regional Anesthesia

Outcome Measures

Primary Outcomes (1)

• intraoperative haemodynamic parameters

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

  intraoperative 2 hours

Secondary Outcomes (4)

• Entropy

  intraoperative 2 hours

• SPI

  intraoperative 2 hours

• sedation and analgesic

  intraoperative 2 hours

• Intraoperative bleeding

  intraoperative 2 hours

Study Arms (3)

hypobaric spinal anaesthesia

ACTIVE COMPARATOR

25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 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.

Procedure: hypobaric spinal anaesthesia

lumbar plexus block

ACTIVE COMPARATOR

A 10-15 cm peripheral block needle, ultrasound and nerve stimulator will be used for lumbar plexus block. Buvicaine with 0.5% Bupivacaine Hydrochloride active substance will be used. It will be diluted half and half with saline. It will be applied in accordance with the patient's height and weight, not exceeding 2mg/kg.

Procedure: lumbar plexus block

hyperbaric spinal anaesthesia

ACTIVE COMPARATOR

25 gauge quincke needle will be used for spinal anaesthesia. After the lateral position is given to the patient with the side to be operated on, the patient will be entered through the appropriate interval (L3-4 or L4-5) to apply hypobaric spinal anaesthesia, and after the feeling of falling in the subdural area is obtained, Cerebro Spinal Fluid arrival will be seen and the drug consisting of 0.5% hyper Bupivacain hydrochloride active ingredient will be applied in the range of 2-4cc according to the patient's height and weight.

Procedure: hyperbaric spinal anesthesia

Interventions

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.

hypobaric spinal anaesthesia

lumbar plexus block PROCEDURE

ultrasound and nerve stimulator will be used for lumbar plexus block

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.

hyperbaric spinal anaesthesia

Eligibility Criteria

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

You may qualify if:

• \>18 years and \<90 years
• ASA (American Society of Anesthesiologists) score between I and IV
• Patients who will undergo femoral neck fracture surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, 16110, 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: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: January 25, 2024
• Study Start: January 25, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 13, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)