Comparison of Regional Anaesthesia Methods for Femoral Neck Fracture Surgery

Not Applicable

Completed

• Conditions: Femoral Neck Fractures; Regional Anesthesia

• Registration Number: NCT06224439
• Lead Sponsor: Bursa Yüksek İhtisas Education and Research Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-16
• Study Start: 2024-01-25
• Study First Posted: 2024-01-25
• Status Verified: 2025-04
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-13
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intraoperative haemodynamic parameters	intraoperative 2 hours	non-invasive systolic, diastolic and mean arterial pressure mean arterial pressure (mm/hg)

Secondary Outcome Measures

Name	Time	Method
Entropy	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.
SPI	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
sedation and analgesic	intraoperative 2 hours	Intraoperative sedation and analgesic need (Whether there was a need or not how much is given in total mg or mcg)
Intraoperative bleeding	intraoperative 2 hours

Trial Locations

Locations (1)

Bursa Yuksek Ihtisas Training and Research Hospital; 🇹🇷 Bursa, Turkey