Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
NCT Number: NCT02431858
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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Notify Me18 year and older
All sexes
Interventional
Phase 4
Nedlands, Western Australia, 6009, Australia
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 The system to be investigated has a catheter over the needle (CON) which is left in place after the needle is withdrawn.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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Australian Therapeutic Goods Registry (ATGR) no: 133630
Other names: Australian Therapeutic Goods Registry (ATGR) no: 133630
Time frame: 2 days post insertion
Any leakage around the catheter insertion site as assessed by visual inspection.
Time frame: 2 days
Secondary failure is when a nerve catheter that was previously working has ceased to provide analgesia.
Time frame: intraoperative
Assess the anaesthetist's opinion on the ease of insertion of the different catheters
Time frame: intraoperative
Assessing the needle visibility in the two different catheter systems.
Sir Charles Gairdner Hospital
Other
Catheter Over Needle Technique Causes Less Leakage and Secondary Failure Than Catheter Through Needle Technique for Continuous Femoral Nerve Block
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