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Clinical Trials/NCT06224439
NCT06224439
Completed
Not Applicable

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

Bursa Yuksek Ihtisas Training and Research Hospital1 site in 1 country300 target enrollmentJanuary 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Femoral Neck Fractures
Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Enrollment
300
Locations
1
Primary Endpoint
intraoperative haemodynamic parameters
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2024
End Date
April 13, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bursa Yuksek Ihtisas Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Korgün Ökmen

Principal Investigator

Bursa Yuksek Ihtisas Training and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

intraoperative haemodynamic parameters

Time Frame: intraoperative 2 hours

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

Secondary Outcomes

  • Entropy(intraoperative 2 hours)
  • SPI(intraoperative 2 hours)
  • sedation and analgesic(intraoperative 2 hours)
  • Intraoperative bleeding(intraoperative 2 hours)

Study Sites (1)

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