Catheter Over Needle vs Catheter Through Needle

Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02431858
• Other study ID #: 2015-011
• Status: Completed
• Phase: Phase 4
• First received: April 22, 2015
• Last updated: April 18, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Sir Charles Gairdner Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Catheterization
• Nerve Block

Intervention

Device:
• E-Catheter (Pajunk)

• Sonolong Catheter (Pajunk)

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Sir Charles Gairdner Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter leakage	Any leakage around the catheter insertion site as assessed by visual inspection.	2 days post insertion	No
Secondary	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	No
Secondary	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	No
Secondary	Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.	Assessing the needle visibility in the two different catheter systems.	intraoperative	No