Catheter Over Needle vs Catheter Through Needle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-02-29

Brief Summary

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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.

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Detailed Description

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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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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.

Conditions

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Nerve Block Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Catheter Over Needle

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

Group Type EXPERIMENTAL

E-Catheter (Pajunk)

Intervention Type DEVICE

Catheter through needle

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

Group Type ACTIVE_COMPARATOR

Sonolong Catheter (Pajunk)

Intervention Type DEVICE

Interventions

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E-Catheter (Pajunk)

Intervention Type DEVICE

Sonolong Catheter (Pajunk)

Intervention Type DEVICE

Other Intervention Names

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Australian Therapeutic Goods Registry (ATGR) no: 133630 Australian Therapeutic Goods Registry (ATGR) no: 133630

Eligibility Criteria

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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