Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000689279
Ethics application status
Approved
Date submitted
6/08/2009
Date registered
12/08/2009
Date last updated
29/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fascia Iliaca Block with and without ultrasound for knee surgery.
Scientific title
Fascia Iliaca Block with and without ultrasound for knee surgery.
Secondary ID [1] 273490 0
FIBBUS
Universal Trial Number (UTN)
Trial acronym
FIBUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fascia iliaca block 243471 0
Condition category
Condition code
Anaesthesiology 239772 239772 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After informed consent, patients will be assigned, by using a computer-generated block randomization, to either group 1 - ultrasound guided fascia iliaca block, or group 2 - fascia iliaca block with loss of resistance blind technique.
Patient will receive routine general anaesthetic for the operation as per the discretion of the anaesthetist. Allowable analgesics include alfentanil/ fentanyl for induction.
After the patient is asleep, Group 1 patient will then have a fascia iliaca block placed with ultrasound assistance. The fascia iliaca and the iliacus muscle are identified. An 18 gauge Touhy needle will be inserted under the fascia iliaca with ultrasound guidance. Group 2 patient will have the fascia iliaca block performed by anatomical landmark technique alone. The line from the anterior superior iliac spine and pubic tubercle is drawn. The insertion point is at the lateral 1/3 and medial 2/3 and 1cm caudad to the line drawn. Again an 18 gauge Tuohy needle will be inserted using 2-pop loss of resistance technique. All blocks will be performed by anaesthetists who are proficient at blocks without ultrasound, and who have been trained in the use of ultrasound for vascular access or other nerve blocks. The investigator will be present if required to provide guidance.
For both groups, a total of 0.5ml/kg 0.5% ropivacaine (maximum of 40ml) will be injected through the Tuohy needle in 5ml aliquots after negative aspiration.
Morphine can be administered during the operation as per the discretion of the anaesthetist. Non-steroidal anti-inflammatory drugs (NSAIDS) and tramadol will not be allowed intra-operatively or post-operatively for 48hours. Paracetamol will be given strictly 6-hourly (QID).
A morphine patient controlled analgesia pump will be commenced post-operatively. A blinded research nurse or investigator would then collect the data required from this study.
Intervention code [1] 237090 0
Treatment: Other
Comparator / control treatment
Performing block with ultrasound guidance versus without ultrasound
Control group
Active

Outcomes
Primary outcome [1] 240538 0
24 hour cumulative morphine consumption from medical records - including anaesthetics charts and patient-controlled analgesic forms.
Timepoint [1] 240538 0
24 hours post first dose of morphine administration
Secondary outcome [1] 257106 0
pain scores - visual analogue score
Timepoint [1] 257106 0
24 hours post first dose of morphine administration
Secondary outcome [2] 257107 0
48 hours cumulative morphine consumption - from medical records including anaesthetics charts and patient-controlled analgesics charts.
Timepoint [2] 257107 0
48 hours post first dose of morphine administration
Secondary outcome [3] 257108 0
pain score - visual analogue score
Timepoint [3] 257108 0
48 hours post first dose of morphine administration
Secondary outcome [4] 257109 0
quality of recovery score using questionnaires.
Timepoint [4] 257109 0
48 hours post first dose of morphine administration

Eligibility
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status classification system 1, 2, or 3 who are scheduled for elective unilateral total knee replacement under general anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients who are unable to consent (patient’s refusal, non-English speaking or less than 18 years of age), pregnant and lactating patients, patients having spinal anaesthetic, patients having bilateral surgery or patients with drug allergy to ropivacaine, morphine or panadol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient identified in preadmission clinic, consented and computer randomised to the allocated group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237464 0
Hospital
Name [1] 237464 0
Royal Melbourne Hospital
Country [1] 237464 0
Australia
Primary sponsor type
Hospital
Name
The Royal Melbourne Hospital
Address
Grattan street, Parkville, VIC 3050
Country
Australia
Secondary sponsor category [1] 236951 0
None
Name [1] 236951 0
Address [1] 236951 0
Country [1] 236951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239592 0
Human Research and Ethics Committees (HREC) Melbourne Health
Ethics committee address [1] 239592 0
Ethics committee country [1] 239592 0
Australia
Date submitted for ethics approval [1] 239592 0
Approval date [1] 239592 0
15/07/2009
Ethics approval number [1] 239592 0
HREC 2009.052

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30018 0
Address 30018 0
Country 30018 0
Phone 30018 0
Fax 30018 0
Email 30018 0
Contact person for public queries
Name 13265 0
Irene Ng
Address 13265 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, VIC 3050
Country 13265 0
Australia
Phone 13265 0
+61-3-93427540
Fax 13265 0
Email 13265 0
[email protected]
Contact person for scientific queries
Name 4193 0
Irene Ng
Address 4193 0
Department of Anaesthesia and Pain Management, Royal Melbourne Hospital, Parkville, VIC 3050
Country 4193 0
Australia
Phone 4193 0
+61-3-93427540
Fax 4193 0
Email 4193 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.