Analgesia, Delirium, Delirium in Old Age, Dementia, Hip Fractures, Mental Status Change, Pain
Conditions
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
Interventions
OTHERfascia iliaca compartment block with ropivacaine
the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)
the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)
Sponsors
KAT General Hospital
Aretaieion University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to 105 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mini Mental State examination | arrival to the emergency room | Mini Mental State examination on arrival to the emergency room |
| tramadol consumption | 1-8 days postoperatively | tramadol consumption postoperatively |
| Confusion Assessment Method | arrival to the emergency room | Confusion Assessment Method on arrival to the emergency room |
| requests for analgesia | 1-8 days postoperatively | requests for analgesia postoperatively |
Countries
Greece
Contacts
Primary ContactKassiani Theodoraki, PhD, DESA
Backup ContactKrystallia Vitoula, MD
Outcome results
None listed