Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02431858




Registration number
NCT02431858
Ethics application status
Date submitted
22/04/2015
Date registered
1/05/2015
Date last updated
19/04/2016

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
2015-011
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

Intervention/exposure
Study type
Interventional
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

Outcomes
Primary outcome [1] 0 0
Catheter leakage
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.
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.
Timepoint [2] 0 0
intraoperative
Secondary outcome [3] 0 0
Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.
Timepoint [3] 0 0
intraoperative

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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
Treatment
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
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2016
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Other
Name
Sir Charles Gairdner Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/ct2/show/NCT02431858
Trial related presentations / publications
Public notes

Contacts
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02431858