Clinical trial NCT04404959: Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Official title: Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Delirium in Old Age
Hip Fractures
Dementia
Pain
Analgesia
Mental Status Change
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
Collaborators: name: KAT General Hospital
First posted: 2020-05-28
Enrollment: 80
Sex: ALL
Minimum age (years): 75
Maximum age (years): 105
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
measure: pain score 30 minutes after fascia iliaca block
timeFrame: 30 minutes after performance of fascia iliaca block
measure: pain score 12 hours after fascia iliaca block
timeFrame: 12 hours after performance of fascia iliaca block
Secondary outcomes:
measure: pain score 1-8 days after fascia iliaca block
timeFrame: 1-8 days after fascia iliaca block
Other outcomes:
measure: Mini Mental State examination
timeFrame: arrival to the emergency room
measure: Mini Mental State examination
timeFrame: 1-8 days postoperatively
measure: Confusion Assessment Method
timeFrame: arrival to the emergency room
measure: Confusion Assessment Method
timeFrame: 1-8 days postoperatively
measure: requests for analgesia
timeFrame: 1-8 days postoperatively
measure: tramadol consumption
timeFrame: 1-8 days postoperatively
Locations:
city: Kifisiá
country: Greece
facility: KAT General Hospital of Athens
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki, PhD, DESA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.