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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02689388
Ethics application status
Date submitted
18/02/2016
Date registered
24/02/2016

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
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
Injuries and Accidents 0 0 0 0
Fractures
Musculoskeletal 0 0 0 0
Other muscular and skeletal 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
Timepoint [1] 0 0
immeidately to 5 days post operatively
Secondary outcome [1] 0 0
Decreased recovery time after surgery
Timepoint [1] 0 0
immediately - immediately - 90 days
Secondary outcome [2] 0 0
Decrease post-operative opioid consumption
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
Sex
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
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/08/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
Accrual to date
Final
20
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
Government body
Name
Auckland City Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There is no current plan to share individual subject data


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02689388