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Clinical Trials/NCT04404959
NCT04404959
Unknown
Not Applicable

Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Aretaieion University Hospital1 site in 1 country80 target enrollmentMay 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Aretaieion University Hospital
Enrollment
80
Locations
1
Primary Endpoint
pain score 30 minutes after fascia iliaca block
Last Updated
3 years ago

Overview

Brief Summary

The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Detailed Description

Geriatric patients suffer from hip fractures very often. Delirium is a perioperative neuropsychiatric complication that is characterized by sudden change of mental status, inattention, disorientation and memory impairment with fluctuations of symptoms during the day. Delirium causes increased morbidity and mortality, decreased postoperative functional activity and may predispose to dementia. Perioperative pain may be an important predisposing factor to delirium. Intravenous opioids have been widely used to relieve patients with hip fracture from pain, but they have a lot of complications and have been correlated with delirium as well. Fascia Iliaca compartment block is a peripheral compartment nerve block that is used in hip surgeries. Use of this compartment nerve block to protect geriatric patients from delirium has not been studied. The objective of this trial will be to establish whether the ultrasound-guided suprainguinal fascia iliaca compartment block is capable of protecting geriatric patients with hip fracture from delirium as compared to placebo

Registry
clinicaltrials.gov
Start Date
May 10, 2019
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Kassiani Theodoraki

Professor of Anesthesiology

Aretaieion University Hospital

Eligibility Criteria

Inclusion Criteria

  • geriatric patients
  • American Society of Anesthesiologists (ASA) I-III
  • hip fracture patients

Exclusion Criteria

  • communication or language barriers
  • patients with nutritional problems
  • bedridden patients

Outcomes

Primary Outcomes

pain score 30 minutes after fascia iliaca block

Time Frame: 30 minutes after performance of fascia iliaca block

pain score by the use of Numeric Rating Scale (NRS) 30 minutes after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

pain score 12 hours after fascia iliaca block

Time Frame: 12 hours after performance of fascia iliaca block

pain score by the use of Numeric Rating Scale (NRS) 12 hours after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

Secondary Outcomes

  • pain score 1-8 days after fascia iliaca block(1-8 days after fascia iliaca block)

Study Sites (1)

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