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| Name | Class |
|---|---|
| KAT General Hospital | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fascia iliaca compartment block with ropivacaine | Active Comparator | in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25% |
|
| fascia iliaca compartment block with placebo | Placebo Comparator | in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fascia iliaca compartment block with ropivacaine | Other | 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%) |
| Measure | Description | Time Frame |
|---|---|---|
| pain score 30 minutes after 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" | 30 minutes after performance of fascia iliaca block |
| pain score 12 hours after 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" | 12 hours after performance of fascia iliaca block |
| Measure | Description | Time Frame |
|---|---|---|
| pain score 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" | 1-8 days after fascia iliaca block |
| Measure | Description | Time Frame |
|---|---|---|
| Mini Mental State examination | Mini Mental State examination on arrival to the emergency room | arrival to the emergency room |
| Mini Mental State examination | Mini Mental State examination postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Contact | +306974634162 | ktheodoraki@hotmail.com | |
| Krystallia Vitoula, MD | Contact | kvitoula@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassiani Theodoraki, PhD, DESA | Aretaieion University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KAT General Hospital of Athens | Recruiting | Kifissia | 14561 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32360090 | Background | Unneby A, Svensson PO, Gustafson PY, Lindgren APB, Bergstrom U, Olofsson PB. Complications with focus on delirium during hospital stay related to femoral nerve block compared to conventional pain management among patients with hip fracture - A randomised controlled trial. Injury. 2020 Jul;51(7):1634-1641. doi: 10.1016/j.injury.2020.04.013. Epub 2020 Apr 20. | |
| 32281905 |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D006620 | Hip Fractures |
| D003704 | Dementia |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| fascia iliaca compartment block with placebo | Other | 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) |
|
|
| 1-8 days postoperatively |
| Confusion Assessment Method | Confusion Assessment Method on arrival to the emergency room | arrival to the emergency room |
| Confusion Assessment Method | Confusion Assessment Method postoperatively | 1-8 days postoperatively |
| requests for analgesia | requests for analgesia postoperatively | 1-8 days postoperatively |
| tramadol consumption | tramadol consumption postoperatively | 1-8 days postoperatively |
| Zhao X, Yuan W. Perioperative Multicomponent Interdisciplinary Program Reduces Delirium Incidence in Elderly Patients With Hip Fracture. J Am Psychiatr Nurses Assoc. 2022 Mar;28(2):154-163. doi: 10.1177/1078390320915250. Epub 2020 Apr 13. |
| 32251149 | Background | Poeran J, Cozowicz C, Zubizarreta N, Weinstein SM, Deiner SG, Leipzig RM, Friedman JI, Liu J, Mazumdar M, Memtsoudis SG. Modifiable factors associated with postoperative delirium after hip fracture repair: An age-stratified retrospective cohort study. Eur J Anaesthesiol. 2020 Aug;37(8):649-658. doi: 10.1097/EJA.0000000000001197. |
| 31942744 | Background | Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gumus Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002. |
| 29278266 | Background | Scurrah A, Shiner CT, Stevens JA, Faux SG. Regional nerve blockade for early analgesic management of elderly patients with hip fracture - a narrative review. Anaesthesia. 2018 Jun;73(6):769-783. doi: 10.1111/anae.14178. Epub 2017 Dec 26. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D010468 | Perceptual Disorders |
| D000588 |
| Amines |
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |