DeliriumRASAPODNCT02689388
Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery.
A study testing Femoral Nerve Block in people with Delirium and Hip Fracture, run by Auckland City Hospital at 1 site in New Zealand.
Trial summary
Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium, Hip Fracture
- What is being tested?
- Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Aug 2016to 31 Dec 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Greater than or equal to 65 years
- Have a hip fracture requiring surgery
- Written informed consent for participation of study prior to surgery.
Who cannot join
- Contraindication to peripheral nerve block or local anaesthetics
- Unable to do delirium or cognitive testing due to language, vision or hearing impairment
- Unable to communicate with research staff due to language barriers
- History of chronic opioid use (longer than 1 month)
- Contraindication to general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Post-operative Regional Analgesia Rather Than Systemic Analgesia to Decrease the Incidence of Post-operative Delirium After Acute Hip Fracture Surgery? A Prospective Randomized-controlled Double-blinded Pilot Study.
Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain relief (analgesia) treatments may also influence the incidence of delirium, but more research is needed into which techniques are effective in improving patient outcomes, care and decreasing costs. This pilot study compares the addition of regional analgesia as part of general anesthesia to determine the incidence of delirium following hip surgery. This is a collaborative study involving anesthesia, orthopedic surgery and geriatrics in the improvement of patient care.
- Conditions
- Delirium, Hip Fracture
- Being tested
- Femoral Nerve Block
- Keywords
- analgesia, regional analgesia, femoral nerve block, older persons, frail
- Medical subject headings
- Delirium, Hip Fractures, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral Nerve BlockProcedure or surgery
Also called Nerve Block, Regional Anesthesia
Use of femoral nerve block as part of general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia with nerve block | Active comparator | Femoral Nerve Block Receives: Procedure: Femoral Nerve Block |
| General Anesthesia no nerve block | No intervention | No femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of post-operative delirium after hip fracture surgery
Identify the our local incidence of post operative delirium diagnosed with 3D-CAM (3 Minute Diagnostic Assessment for Confusion Assessment Method)
Measured: immeidately to 5 days post operatively
Secondary outcomes (2)
Decreased recovery time after surgery
reduction in length of stay and recovery time
Measured: immediately - immediately - 90 days
Decrease post-operative opioid consumption
reduction in the requirement for systemic/opiod analgesia
Measured: immediately - immediately - 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study start28 Aug 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Why it stopped: Feasibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Auckland City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assoc. Prof Timothy Short, Auckland City Hospital
- Investigators
- Tin L Chiu, MBChB, Principal investigator, Auckland City Hospital - Anaesthesia and Peri-Operative Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689388
- Sponsor's protocol ID
- ADHB_6925
- Acronym
- RASAPOD
- Status last verified
- Jul 2021
- First submitted
- 18 Feb 2016
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual subject data
Publications
Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Post-operative Regional Analgesia Rather Than Systemic Analgesia to Decrease the Incidence of Post-operative Delirium After Acute Hip Fracture Surgery? A Prospective Randomized-controlled Double-blinded Pilot Study.
- ClinicalTrials.gov ID
- NCT02689388
- Acronym / sponsor ID
- RASAPOD / ADHB_6925
- Conditions
- Delirium, Hip Fracture
- Keywords
- analgesia, regional analgesia, femoral nerve block, older persons, frail
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Feasibility
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Auckland City HospitalOther government
- Study start
- 28 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 24 Feb 2016 (estimated)
- 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.
Post operative delirium is common after hip fracture surgery and is associated with increased length of hospital stay, delayed recovery and increased mortality. Postoperative delirium can also decrease a patient's quality of life and increase treatment costs. Anesthesia and pain relief (analgesia) treatments may also influence the incidence of delirium, but more research is needed into which techniques are effective in improving patient outcomes, care and decreasing costs. This pilot study compares the addition of regional analgesia as part of general anesthesia to determine the incidence of delirium following hip surgery. This is a collaborative study involving anesthesia, orthopedic surgery and geriatrics in the improvement of patient care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia with nerve block | Active comparator | Procedure: Femoral Nerve BlockFemoral Nerve Block |
| General Anesthesia no nerve block | No intervention | –No femoral Nerve Block |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Greater than or equal to 65 years
- Have a hip fracture requiring surgery
- Written informed consent for participation of study prior to surgery.
Key exclusion criteria (5 listed)
- Contraindication to peripheral nerve block or local anaesthetics
- Unable to do delirium or cognitive testing due to language, vision or hearing impairment
- Unable to communicate with research staff due to language barriers
- History of chronic opioid use (longer than 1 month)
- Contraindication to general anesthesia
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 |
|---|---|---|
| Femoral Nerve BlockAlso: Nerve Block, Regional AnesthesiaUse of femoral nerve block as part of general anesthesia | Procedure or surgery | General Anesthesia with nerve block |
Primary outcome
The incidence of post-operative delirium after hip fracture surgery
Time frame: immeidately to 5 days post operatively
Identify the our local incidence of post operative delirium diagnosed with 3D-CAM (3 Minute Diagnostic Assessment for Confusion Assessment Method)
2 secondary outcomes
Decreased recovery time after surgery
Time frame: immediately - immediately - 90 days
Decrease post-operative opioid consumption
Time frame: immediately - immediately - 90 days
Results and safety
The study was stopped early (reason given: Feasibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Derived from this study: PubMed 33238043Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
- Individual participant dataSharing planned: No. There is no current plan to share individual subject data
Related trials for Delirium
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Tin L Chiu, MBChB principal investigator
Auckland City Hospital - Anaesthesia and Peri-Operative Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral Nerve Block in people with Delirium and Hip Fracture, run by Auckland City Hospital at 1 site in New Zealand.
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 5 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: stopped early, as of the sponsor's last update on 28 Jul 2021. 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 New Zealand. 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. 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?
The study was stopped early (reason given: Feasibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of post-operative delirium after hip fracture surgery (time frame: immeidately to 5 days post operatively). 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 NCT02689388, which also lists 1 linked publication.
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 28 Jul 2021.