Catheter Over Needle vs Catheter Through Needle

Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block

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.

Study Overview

• Status: Completed
• Conditions: Nerve Block; Catheterization
• Intervention / Treatment: Device: E-Catheter (Pajunk); Device: Sonolong Catheter (Pajunk)

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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Catheter Over Needle; The femoral nerve catheter used will be the "E-Catheter" (Pajunk) device which is a novel catheter over needle system.	Device: E-Catheter (Pajunk); Other Names: Australian Therapeutic Goods Registry (ATGR) no: 133630
Active Comparator: Catheter through needle; The femoral nerve catheter used will be the "Sonolong" catheter (Pajunk) which is a traditional catheter through needle system.	Device: Sonolong Catheter (Pajunk); Other Names: Australian Therapeutic Goods Registry (ATGR) no: 133630

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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.	Assess the anaesthetist's opinion on the ease of insertion of the different catheters	intraoperative
Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.	Assessing the needle visibility in the two different catheter systems.	intraoperative

Collaborators and Investigators

• Sponsor: Sir Charles Gairdner Hospital
• Investigators: Principal Investigator: Richard M Edwards, MBBS, Sir Charles Gairdner Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 22, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimate): May 1, 2015

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Anaesthesia; Catheter; Nerve block; Femoral Nerve; Catheter over needle; [E04.525.210.550]; [E02.148]
• Other Study ID Numbers: 2015-011