DeliriumDelirium-HipNCT04404959
Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
A study testing fascia iliaca compartment block with ropivacaine in people with Delirium and Delirium in Old Age, run by Aretaieion University Hospital at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Ages 75 to 105 years
- Conditions the study is for
- Delirium, Delirium in Old Age, Hip Fractures
- What is being tested?
- fascia iliaca compartment block with ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- 10 May 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 105 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- geriatric patients
- American Society of Anesthesiologists (ASA) I-III
- hip fracture patients
Who cannot join
- dementia
- communication or language barriers
- patients with nutritional problems
- bedridden patients
Trial locations and contacts
1 site in 1 country.
Krystallia Vitoula, MD contact
Greece1 site, 1 recruiting
- Recruiting
KAT General Hospital of Athens
Kifissia, 14561
Kassiani Theodoraki, Phd, DESA, +306974634162, ktheodoraki@hotmail.com
Krystallia vitoula, MD, kvitoula@yahoo.com
About this study
Official title: Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
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
Read the 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
- Conditions
- Delirium, Delirium in Old Age, Hip Fractures, Dementia, Pain, Analgesia
- Being tested
- fascia iliaca compartment block with ropivacaine, fascia iliaca compartment block with placebo
- Medical subject headings
- Delirium, Hip Fractures, Dementia, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fascia iliaca compartment block with ropivacaineOther
Also called medication in regional anesthetic technique
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 placeboOther
Also called medication in regional anesthetic technique
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)
| Study group | Role | What they receive |
|---|---|---|
| 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% Receives: Other: fascia iliaca compartment block with ropivacaine |
| fascia iliaca compartment block with placebo | Placebo comparator | in this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline Receives: Other: fascia iliaca compartment block with placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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"
Measured: 12 hours after performance of fascia iliaca block
Secondary outcomes (1)
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"
Measured: 1-8 days after fascia iliaca block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start10 May 2019
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- KAT General Hospital
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DESA, Principal investigator, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404959
- Sponsor's protocol ID
- Delirium-Pain-Hip Fracture
- Acronym
- Delirium-Hip
- Status last verified
- Jul 2022
- First submitted
- 22 May 2020
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32360090Zhao 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.
PubMed 32281905Poeran 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.
PubMed 32251149Uysal 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.
PubMed 31942744Scurrah 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.
PubMed 29278266
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Perioperative Pain and Delirium in Geriatric Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT04404959
- Acronym / sponsor ID
- Delirium-Hip / Delirium-Pain-Hip Fracture
- Conditions
- Delirium, Delirium in Old Age, Hip Fractures, Dementia, Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Collaborators
- KAT General Hospital
- Study start
- 10 May 2019 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fascia iliaca compartment block with ropivacaine | Active comparator | Other: fascia iliaca compartment block with ropivacainein this arm, the fascia iliaca compartment block will be performed with 40 mL ropivacaine 0.25% |
| fascia iliaca compartment block with placebo | Placebo comparator | Other: fascia iliaca compartment block with placeboin this arm, the fascia iliaca compartment block will be performed with 40 mL normal saline |
Who may qualify
- Ages
- 75 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- geriatric patients
- American Society of Anesthesiologists (ASA) I-III
- hip fracture patients
Key exclusion criteria (4 listed)
- dementia
- communication or language barriers
- patients with nutritional problems
- bedridden patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fascia iliaca compartment block with ropivacaineAlso: medication in regional anesthetic techniquethe 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%) | Other | fascia iliaca compartment block with ropivacaine |
| fascia iliaca compartment block with placeboAlso: medication in regional anesthetic techniquethe 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) | Other | fascia iliaca compartment block with placebo |
Primary outcome
pain score 30 minutes after fascia iliaca block
Time frame: 30 minutes after performance of 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
Time frame: 12 hours after performance of 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"
1 secondary outcome
pain score 1-8 days after fascia iliaca block
Time frame: 1-8 days after fascia iliaca block
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Background: PubMed 32360090Unneby 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.
- Background: PubMed 32281905Zhao 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.
- Background: PubMed 32251149Poeran 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.
- Background: PubMed 31942744Uysal 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.
- Background: PubMed 29278266Scurrah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Krystallia Vitoula, MD contact
Kassiani Theodoraki, PhD, DESA principal investigator
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fascia iliaca compartment block with ropivacaine in people with Delirium and Delirium in Old Age, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DESA (+306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score 30 minutes after fascia iliaca block (time frame: 30 minutes after performance of fascia iliaca block). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04404959, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.