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Completed

NCT Number: NCT02431858

Catheter Over Needle vs Catheter Through Needle

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

About this study

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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

E-Catheter (Pajunk)

Device

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

Sonolong Catheter (Pajunk)

Device

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

Primary outcomes

  1. Catheter leakage

    Time frame: 2 days post insertion

    Any leakage around the catheter insertion site as assessed by visual inspection.

Secondary outcomes

  1. Overall rate of secondary failure as assessed by the acute pain service on days 1 and 2 post op.

    Time frame: 2 days

    Secondary failure is when a nerve catheter that was previously working has ceased to provide analgesia.

  2. Ease of insertion assessed by the inserting anaesthetist on a 5 point Likert scale.

    Time frame: intraoperative

    Assess the anaesthetist's opinion on the ease of insertion of the different catheters

  3. Needle visibility assessed by the inserting anaesthetist on a 5 point Likert scale.

    Time frame: intraoperative

    Assessing the needle visibility in the two different catheter systems.

Sponsors and collaborators

Lead sponsor

Sir Charles Gairdner Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 1, 2015
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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