Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture (Delirium-Hip)

Aretaieion University Hospital

Status: Enrolling

Conditions: Hip Fractures; Delirium; Mental Status Change; Analgesia; Delirium in Old Age; Pain; Dementia

Treatments: Other: fascia iliaca compartment block with placebo; Other: fascia iliaca compartment block with ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04404959

Delirium-Pain-Hip Fracture

Details and patient eligibility

About

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

Full 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

Enrollment: 80 estimated patients

Sex: All

Ages: 75 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

fascia iliaca compartment block with ropivacaine

Active Comparator group

Description:

in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%

Treatment:

Other: fascia iliaca compartment block with ropivacaine

fascia iliaca compartment block with placebo

Placebo Comparator group

Description:

in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline

Treatment:

Other: fascia iliaca compartment block with placebo