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Catheter Over Needle vs Catheter Through Needle

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ClinicalTrials.gov Identifier: NCT02431858
Recruitment Status : Completed
First Posted : May 1, 2015
Last Update Posted : April 19, 2016
Sponsor:
Information provided by (Responsible Party):
Richard Edwards, Sir Charles Gairdner Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Nerve Block Catheterization Device: E-Catheter (Pajunk) Device: Sonolong Catheter (Pajunk) Phase 4

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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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




Primary Outcome Measures :
  1. Catheter leakage [ Time Frame: 2 days post insertion ]
    Any leakage around the catheter insertion site as assessed by visual inspection.


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02431858


Locations
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Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Sir Charles Gairdner Hospital
Investigators
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Principal Investigator: Richard M Edwards, MBBS Sir Charles Gairdner Hospital
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Responsible Party: Richard Edwards, Principle Investigator, Sir Charles Gairdner Hospital
ClinicalTrials.gov Identifier: NCT02431858    
Other Study ID Numbers: 2015-011
First Posted: May 1, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016
Keywords provided by Richard Edwards, Sir Charles Gairdner Hospital:
Nerve block
Catheter
Catheter over needle
Femoral Nerve
Anaesthesia
[E04.525.210.550]
[E02.148]