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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Catheter Over Needle vs Catheter Through Needle
Scientific title
Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nerve Block 0 0
Catheterization 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Devices - E-Catheter (Pajunk)
Treatment: Devices - Sonolong Catheter (Pajunk)

Experimental: Catheter Over Needle - The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system.

Active Comparator: Catheter through needle - The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system.

Treatment: Devices: E-Catheter (Pajunk)

Treatment: Devices: Sonolong Catheter (Pajunk)

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

Primary outcome [1] 0 0
Catheter leakage - Any leakage around the catheter insertion site as assessed by visual inspection.
Timepoint [1] 0 0
2 days post insertion
Secondary outcome [1] 0 0
Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op. - Secondary failure is when a nerve catheter that was previously working has ceased to provide analgesia.
Timepoint [1] 0 0
2 days
Secondary outcome [2] 0 0
Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale. - Assess the anaesthetist's opinion on the ease of insertion of the different catheters
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale. - Assessing the needle visibility in the two different catheter systems.
Timepoint [3] 0 0

Key inclusion criteria
- Patients presenting to Sir Charles Gairdner Hospital for elective, unilateral, primary
total knee replacement.

- Body mass index 18-40 kg/m2

- American Society of Anaesthetists (ASA) grade I-III
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Allergy to local anaesthetic

- Inability to cooperate

- Inability to read, speak and understand English

- Less than 18 years old

Study design
Purpose of the study
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

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Sir Charles Gairdner Hospital

Ethics approval
Ethics application status

Brief summary
To randomize 108 patients undergoing knee replacement surgery to catheter through needle or
catheter over needle femoral nerve blocks, then monitor the catheters for leakage to see if
there is a difference.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Richard M Edwards, MBBS
Address 0 0
Sir Charles Gairdner Hospital
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

Summary results
Other publications