Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
Delirium-Hip
Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2020
CompletedFirst Posted
Study publicly available on registry
May 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJuly 12, 2022
July 1, 2022
4.6 years
May 22, 2020
July 10, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
pain score 1-8 days after fascia iliaca block
1-8 days after fascia iliaca block
Other Outcomes (6)
Mini Mental State examination
arrival to the emergency room
Mini Mental State examination
1-8 days postoperatively
Confusion Assessment Method
arrival to the emergency room
- +3 more other outcomes
Study Arms (2)
fascia iliaca compartment block with ropivacaine
ACTIVE COMPARATORin this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25%
fascia iliaca compartment block with placebo
PLACEBO COMPARATORin this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline
Interventions
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)
Eligibility Criteria
You may qualify if:
- geriatric patients
- American Society of Anesthesiologists (ASA) I-III
- hip fracture patients
You may not qualify if:
- dementia
- communication or language barriers
- patients with nutritional problems
- bedridden patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aretaieion University Hospitallead
- KAT General Hospitalcollaborator
Study Sites (1)
KAT General Hospital of Athens
Kifissia, 14561, Greece
Related Publications (5)
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.
PMID: 32360090BACKGROUNDZhao 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.
PMID: 32281905BACKGROUNDPoeran 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.
PMID: 32251149BACKGROUNDUysal 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.
PMID: 31942744BACKGROUNDScurrah 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.
PMID: 29278266BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kassiani Theodoraki, PhD, DESA
Aretaieion University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology
Study Record Dates
First Submitted
May 22, 2020
First Posted
May 28, 2020
Study Start
May 10, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
July 12, 2022
Record last verified: 2022-07