Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Not Applicable

• Conditions: Hip Fractures; Dementia; Pain; Delirium; Delirium in Old Age; Analgesia; Mental Status Change
• Interventions: Other: fascia iliaca compartment block with placebo; Other: fascia iliaca compartment block with ropivacaine

• Registration Number: NCT04404959
• Lead Sponsor: Aretaieion University Hospital

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

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2020-05-22
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-28
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-10
• Last Update Posted: 2022-07-12
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fascia iliaca compartment block with placebo	fascia iliaca compartment block with placebo	in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
fascia iliaca compartment block with ropivacaine	fascia iliaca compartment block with ropivacaine	in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%

Primary Outcome Measures

Name	Time	Method
pain score 30 minutes after fascia iliaca block	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	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 Outcome Measures

Name	Time	Method
pain score 1-8 days after fascia iliaca block	1-8 days after fascia iliaca block	pain score by the use of Numeric Rating Scale (NRS) 1-8 days after fascia ilaca block, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

Trial Locations

Locations (1)

KAT General Hospital of Athens; 🇬🇷 Kifisiá, Greece