Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture (Delirium-Hip)
Primary Purpose
Delirium, Delirium in Old Age, Hip Fractures
Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
fascia iliaca compartment block with ropivacaine
fascia iliaca compartment block with placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Delirium
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
Sites / Locations
- KAT General Hospital of AthensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
fascia iliaca compartment block with ropivacaine
fascia iliaca compartment block with placebo
Arm Description
in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%
in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
Outcomes
Primary Outcome Measures
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"
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"
Secondary Outcome Measures
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"
Full Information
NCT ID
NCT04404959
First Posted
May 22, 2020
Last Updated
July 10, 2022
Sponsor
Aretaieion University Hospital
Collaborators
KAT General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04404959
Brief Title
Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Acronym
Delirium-Hip
Official Title
Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital
Collaborators
KAT General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Delirium in Old Age, Hip Fractures, Dementia, Pain, Analgesia, Mental Status Change
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
fascia iliaca compartment block with ropivacaine
Arm Type
Active Comparator
Arm Description
in this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%
Arm Title
fascia iliaca compartment block with placebo
Arm Type
Placebo Comparator
Arm Description
in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
Intervention Type
Other
Intervention Name(s)
fascia iliaca compartment block with ropivacaine
Other Intervention Name(s)
medication in regional anesthetic technique
Intervention Description
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%)
Intervention Type
Other
Intervention Name(s)
fascia iliaca compartment block with placebo
Other Intervention Name(s)
medication in regional anesthetic technique
Intervention Description
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)
Primary Outcome Measure Information:
Title
pain score 30 minutes after fascia iliaca block
Description
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"
Time Frame
30 minutes after performance of fascia iliaca block
Title
pain score 12 hours after fascia iliaca block
Description
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"
Time Frame
12 hours after performance of fascia iliaca block
Secondary Outcome Measure Information:
Title
pain score 1-8 days after fascia iliaca block
Description
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"
Time Frame
1-8 days after fascia iliaca block
Other Pre-specified Outcome Measures:
Title
Mini Mental State examination
Description
Mini Mental State examination on arrival to the emergency room
Time Frame
arrival to the emergency room
Title
Mini Mental State examination
Description
Mini Mental State examination postoperatively
Time Frame
1-8 days postoperatively
Title
Confusion Assessment Method
Description
Confusion Assessment Method on arrival to the emergency room
Time Frame
arrival to the emergency room
Title
Confusion Assessment Method
Description
Confusion Assessment Method postoperatively
Time Frame
1-8 days postoperatively
Title
requests for analgesia
Description
requests for analgesia postoperatively
Time Frame
1-8 days postoperatively
Title
tramadol consumption
Description
tramadol consumption postoperatively
Time Frame
1-8 days postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Krystallia Vitoula, MD
Email
kvitoula@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DESA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KAT General Hospital of Athens
City
Kifisiá
ZIP/Postal Code
14561
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, Phd, DESA
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Krystallia vitoula, MD
Email
kvitoula@yahoo.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
32360090
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.
Results Reference
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PubMed Identifier
32281905
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.
Results Reference
background
PubMed Identifier
32251149
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.
Results Reference
background
PubMed Identifier
31942744
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.
Results Reference
background
PubMed Identifier
29278266
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.
Results Reference
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Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
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