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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02689388




Registration number
NCT02689388
Ethics application status
Date submitted
18/02/2016
Date registered
24/02/2016
Date last updated
18/07/2017

Titles & IDs
Public title
Evaluating the Addition of Regional Analgesia to Reduce Postoperative Delirium in Patients Having Hip Fracture Surgery.
Scientific 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.
Secondary ID [1] 0 0
ADHB_6925
Universal Trial Number (UTN)
Trial acronym
RASAPOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 0 0
Hip Fracture 0 0
Condition category
Condition code
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Femoral Nerve Block

Active Comparator: General Anesthesia with nerve block - Femoral Nerve Block

No Intervention: General Anesthesia no nerve block - No femoral Nerve Block


Treatment: Surgery: Femoral Nerve Block
Use of femoral nerve block as part of general anesthesia

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
immeidately to 5 days post operatively
Secondary outcome [1] 0 0
Decreased recovery time after surgery - reduction in length of stay and recovery time
Timepoint [1] 0 0
immediately - immediately - 90 days
Secondary outcome [2] 0 0
Decrease post-operative opioid consumption - reduction in the requirement for systemic/opiod analgesia
Timepoint [2] 0 0
immediately - immediately - 90 days

Eligibility
Key inclusion criteria
Inclusion criteria (must meet all 3):

- Greater than or equal to 65 years

- Have a hip fracture requiring surgery

- Written informed consent for participation of study prior to surgery.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Auckland City Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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. 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.
Trial website
https://clinicaltrials.gov/show/NCT02689388
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tin L Chiu, MBChB
Address 0 0
Auckland City Hospital - Anaesthesia and Peri-Operative Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Davina J McAllister
Address 0 0
Country 0 0
Phone 0 0
+6493757095
Fax 0 0
Email 0 0
davinams@adhb.govt.nz
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02689388