Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000401853
Ethics application status
Not yet submitted
Date submitted
22/08/2010
Date registered
10/04/2012
Date last updated
10/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
In patients undergoing ultrasound-guided fascia iliaca compartment blockade before knee replacement surgery, does the addition of hyaluronidase to the local anaesthetic solution improve the success rate and hasten the onset of the nerve blockade?
Scientific title
Does the addition of hyaluronidase to ultrasound-guided fascia iliaca compartment block improve the time to onset and extent of anaesthesia in patients undergoing unlilateral knee arthroplasty?
Secondary ID [1] 252538 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improving regional anaesthesia efficacy 258017 0
Condition category
Condition code
Anaesthesiology 258187 258187 0 0
Anaesthetics
Musculoskeletal 258240 258240 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
30mL 0.5% ropivacaine with/without hyaluronidase powder 1500IU (i.e. 50IU/mL hyaluronidase) will be used for fascia iliaca compartment block. A single block fascia iliaca compartment procedure is performed approximately 30minutes before commencement of surgery. The solution is delivered to the fascia iliaca compartment (deep to the fascia iliaca and superficial to the iliacus muscle in the groin). The needle tip is directed into the correct position with ultrasound guidance.
Intervention code [1] 257062 0
Treatment: Drugs
Comparator / control treatment
30mL 0.5% ropivacaine without hyaluronidase. A single fascia iliaca compartment block procedure is performed approximately 30minutes before commencement of surgery. The solution is delivered to the fascia iliaca compartment (deep to the fascia iliaca and superficial to the iliacus muscle in the groin). The needle tip is directed into the correct position with ultrasound guidance.
Control group
Active

Outcomes
Primary outcome [1] 259045 0
Success of facia iliaca compartment block (success is defined as anaesthesia of 3 nerves - the lateral cutaneous nerve of the thigh (LCNT), the femoral nerve (FN) and the obturator nerve(ON)). Anaesthesia of the LCNT is defined as reduced/absent of cold sensation to ice on the skin of the lateral aspect of the mid-thigh. Anaesthesia of the FN is defined as reduced/absent sensation to cold (using an ice cube) on the anterior aspect of the thigh AND weakness of knee extension with the hip passively flexed. ON anaesthesia is defined as > 20% decrease in 'strength' of thigh adduction (baseline is determined by force measured (mmHg) when teh patients thighs squeeze a sphygmonamometer cuff which has been pre-inflated to a pressure of 40mmHg).
Timepoint [1] 259045 0
0, 5, 10, 15, 20, 25, 30 minutes after block administration
Secondary outcome [1] 265298 0
Speed of onset of fascia iliaca compartment blockade. The proportion of successful LCNT and FN and ON will be measured/compared between groups at 5 minutely time points. Methods to assess success/failure are defined in the explanation of primary outcome
Timepoint [1] 265298 0
0, 5, 10, 15, 20, 25, 30 minutes after block administration
Secondary outcome [2] 265381 0
Plasma ropivacaine levels. Blood samples will be collected at 10, 20 and 30 minutes after block administration. Plasma ropivacaine levels will be determined using a Gas Chromatograph Mass Spectrometer.
Timepoint [2] 265381 0
10, 20, 30 minutes after block administration

Eligibility
Key inclusion criteria
Patients undergoing single-sided, first-time total knee replacement
Male or female; 18-80 years of age at the time of surgery
Must be able to understand the possible anaesthetic complications and study protocol
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any refusal/contraindication to fascia iliaca compartment block
Allergy to study medications
Pregnancy
Inability to communicate with authors
Morbid obesity [Body Mass Index (BMI) > 35kg/m2]
Known hepatic or renal insufficiency
Pre-existing neurological deficit of lower limbs

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)
Interview at pre-anaesthetic assessment
Informed consent
The randomisation sequence will be determined by a computer-generated randomisation program
Sealed opaque enveloped will be numbered according to this randomisation sequence and when opened for each participant will indicate group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3154 0
2050

Funding & Sponsors
Funding source category [1] 257507 0
Hospital
Name [1] 257507 0
Department of Anaesthesia, Royal Prince Alfred Hospital
Country [1] 257507 0
Australia
Funding source category [2] 285061 0
Other
Name [2] 285061 0
Australian and New Zealand College of Anaesthetists
Country [2] 285061 0
Australia
Funding source category [3] 285062 0
Other
Name [3] 285062 0
Australian and New Zealand College of Anaesthetists
Country [3] 285062 0
Australia
Primary sponsor type
Individual
Name
Dr Andrew Kenneth Lansdown
Address
Department of Anaesthesia
Royal Prince Alfred Hospital
Missenden Road
Camperdown. 2050. NSW.
Country
Australia
Secondary sponsor category [1] 256743 0
Individual
Name [1] 256743 0
Dr John Loadsman
Address [1] 256743 0
Department of Anaesthesia
Royal Prince Alfred Hospital
Missenden Road
Camperdown. 2050. NSW.
Country [1] 256743 0
Australia
Secondary sponsor category [2] 283924 0
None
Name [2] 283924 0
Address [2] 283924 0
Country [2] 283924 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259535 0
Royal Prince Alfred Hospital
Ethics committee address [1] 259535 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown. 2050. NSW.
Ethics committee country [1] 259535 0
Australia
Date submitted for ethics approval [1] 259535 0
25/08/2010
Approval date [1] 259535 0
Ethics approval number [1] 259535 0
HREC/10/RPAH/356

Summary
Brief summary
We aim to investigate the effect of the drug hyaluronidase on the efficacy of ultrasound-guided fascia iliaca compartment block (FICB). Hyauluronidase is a naturally occurring enzyme that it available as a drug. It possesses spreading properties and it is used as a pharmaceutical agent to facilitate the dispersion of drugs and other substances. It has been proven to be effective in enhancing ocular regional anaesthesia but it has not been adequately studied in peripheral regional blockade. FICB is a safe and effective method of lumbar plexus regional anaesthesia. The goal of FICB is to provide femoral nerve, lateral cutaneous nerve of the thigh and obturator nerve block. While the femoral nerve and lateral cutaneous nerve of the thigh are reliably blocked by FICB the overall success rate of the block is limited by obturator nerve anaesthesia which is successful in only ~44% of ultrasound guided FICB - presumably due to the distance the local anaesthetic must traverse from its site of infiltration to reach this nerve.

We hypothesise that adding hyaluronidase to a plain 0.5% ropivacine local anaesthetic solution will increase the success of FICB - chiefly the proportion of patients achieving obturator nerve anaesthesia (weakness of thigh adduction). We will also study effects on the speed of onset and blood levels of co-administered local anaesthetic.

An improvement in the success of FICB should improve post-operative pain after knee replacement. If proven, there may also be other peripheral nerve block procedures that may benefit from the addition of hyaluronidase.
Trial website
No trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31552 0
Address 31552 0
Country 31552 0
Phone 31552 0
Fax 31552 0
Email 31552 0
Contact person for public queries
Name 14799 0
Dr Andrew Lansdown
Address 14799 0
Department of Anaesthesia
Royal Prince Alfred Hospital
Missenden Road.
Camperdown. NSW. 2050.
Country 14799 0
Australia
Phone 14799 0
+61 2 9515 6111
Fax 14799 0
Email 14799 0
[email protected]
Contact person for scientific queries
Name 5727 0
Dr Andrew Lansdown
Address 5727 0
Department of Anaesthesia
Royal Prince Alfred Hospital
Missenden Road.
Camperdown. NSW. 2050.
Country 5727 0
Australia
Phone 5727 0
+61 2 9515 6111
Fax 5727 0
Email 5727 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
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Documents added automatically
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