Catheter Over Needle vs Catheter Through Needle

Sir Charles Gairdner Hospital

Status and phase: Completed; Phase 4

Conditions: Nerve Block; Catheterization

Treatments: Device: Sonolong Catheter (Pajunk); Device: E-Catheter (Pajunk)

Study type: Interventional

Funder types: Other

Identifiers

NCT02431858

2015-011

Details and patient eligibility

About

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.

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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Catheter Over Needle

Experimental group

Description:

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

Treatment:

Device: E-Catheter (Pajunk)

Catheter through needle

Active Comparator group

Description:

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

Treatment:

Device: Sonolong Catheter (Pajunk)