Catheter Over Needle vs Catheter Through Needle | NCT02431858

Studies
Catheter Over Needle vs Catheter Through Needle

NCT02431858

Sponsor

Sir Charles Gairdner Hospital

Status

Completed

Last Update Posted

Apr 19, 2016Estimated

Enrollment

110Actual

Phase

Phase 4

Conditions

Nerve Block
Catheterization

Interventions

E-Catheter (Pajunk)
Sonolong Catheter (Pajunk)

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015

Primary Completion Date

Feb 2016Actual

Completion Date

Feb 2016Actual

First Submitted Date

Apr 22, 2015

First Submission Date that Met QC Criteria

Apr 30, 2015

First Posted Date

May 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Richard Edwards, Principle Investigator, Sir Charles Gairdner HospitalPrincipal Investigator

Lead Sponsor

Sir Charles Gairdner HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background: Total Knee Replacement Surgery is a commonly performed procedure that causes significant post-operative pain. Continuous femoral nerve blocks are widely used for analgesia as part of a multimodal analgesic regimen for this surgery. They provide sustained analgesia which allows early physiotherapy for rehabilitation. Currently the most common technique for inserting catheters for continuous femoral nerve blocks is to feed a catheter though a needle (CTN) which has been placed close by the nerve. There is a significant rate of leak and dislodgement of these catheters which can lead secondary failure where the catheter is no longer providing analgesia by blocking the nerve (primary failure occurs when the nerve block catheter fails to provide any analgesia from the start). The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn. The proposed benefit of this is that there will be a reduction in leak rates and dislodgement. This is because using a CON technique means that the biggest hole will be the diameter of the catheter, rather than CTN where the biggest hole will be the diameter of the needle therefore allowing leak around the outside of the catheter.

Objectives: To ascertain whether or not the catheter over needle technique is superior to catheter through needle technique in terms of a leak rate.

Trial plan: To recruit 108 patients who are having total knee replacement surgery into the study and randomise them into having either CON or CTN continuous femoral nerve blocks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Catheter Over Needle	Experimental	The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system.	Device: E-Catheter (Pajunk)
Catheter through needle	Active Comparator	The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system.	Device: Sonolong Catheter (Pajunk)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
E-Catheter (Pajunk)	Device		Catheter Over Needle	Australian Therapeutic Goods Registry (ATGR) no: 133630

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Catheter leakage	Any leakage around the catheter insertion site as assessed by visual inspection.	2 days post insertion

Secondary Outcomes

Measure	Description	Time Frame
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.	2 days
Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

Allergy to local anaesthetic
Inability to cooperate
Inability to read, speak and understand English
Less than 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Richard M Edwards, MBBS	Sir Charles Gairdner Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Charles Gairdner Hospital		Nedlands	Western Australia	6009	Australia