Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Pain Clinical Trial

— Delirium-Hip  

Official title:

Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04404959
• Other study ID #: Delirium-Pain-Hip Fracture
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Aretaieion University Hospital
• Contact: Kassiani Theodoraki, PhD, DESA
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Delirium
• Delirium in Old Age
• Dementia
• Fractures, Bone
• Hip Fractures
• Mental Status Change
• Pain

Intervention

Other:
• fascia 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%)
• fascia iliaca compartment block with placebo
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)

Locations

Country	Name	City	State
Greece	KAT General Hospital of Athens	Kifisiá

Sponsors (2)

Lead Sponsor	Collaborator
Aretaieion University Hospital	KAT General Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View 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. Review. — View Citation

Unneby A, Svensson PO, Gustafson PY, Lindgren APB, Bergström 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. — View Citation

Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gümüs 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mini Mental State examination	Mini Mental State examination on arrival to the emergency room	arrival to the emergency room
Other	Mini Mental State examination	Mini Mental State examination postoperatively	1-8 days postoperatively
Other	Confusion Assessment Method	Confusion Assessment Method on arrival to the emergency room	arrival to the emergency room
Other	Confusion Assessment Method	Confusion Assessment Method postoperatively	1-8 days postoperatively
Other	requests for analgesia	requests for analgesia postoperatively	1-8 days postoperatively
Other	tramadol consumption	tramadol consumption postoperatively	1-8 days postoperatively
Primary	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
Primary	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	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