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Dislocation of the femoral nerve catheters, which are used as postoperative analgesic method after knie surgery, will be studied. Two Groups will be compared; in the first group the femoral nerve catheter will be placed sonographically with the in-plane technique, whereas in the other Group the femoral nerve catheter will be placed sonographically with the out-of-plane technique
Patients scheduled for elective major knee surgery will be assessed for eligibility and after written informed consent included in this clinical trial. Prior to surgery, the patient will receive a femoral catheter with either ultrasound placed in-plane (IP) or with ultrasound placed out-of-plane (OOP) as perioperative analgesic regimen using well-established and previously published techniques. The allocation to the different groups will be according to a computerized random-list established the day prior to surgery. In all cases, continuous regional anaesthesia regimen will be started after surgery. For surgery the patient can receive spinal anaesthesia, or a general anaesthesia. The use of a sciatic block will be applied according to the clinical standards of our department. Ropivacaine 0.3% (bag with 100 ml, Sintetica SA, Mendrisio Switzerland) 20 ml for the femoral catheter insertion. In both groups 10ml of ropivacaine 0.3% will be applied over the needle and 10ml over the catheter after its placement. In both groups the catheters will be connected to the electronic pump in the recovery room and run with ropivacaine 0.3% at 6 ml/h with boli of 4ml every 20min.
First rescue medication: ropivacaine 0.3% 20ml up to 3 x day. The catheters will stay in place for 48 hours and removed only if VAS< 40 with standard analgesia.
At 24 and 48 hours after placement of the femoral catheter, a bolus of NaCl 0.9% 10ml will be applied under ultrasound control in both groups and dislocation will be noted if the local anaesthetic does not reach the femoral nerve. In that case it will be noted where the local anaesthetic is localised. Block quality will be checked by applying cold on the front of the knee and measuring the sensation to cold in a scale from 0 to 2 (before NaCl 0.9% application). Pain will be assessed before the dislocation test only for in front and medial side of the knee in a regularly used NRS scale from 0 to 10. Complications and side effects of regional anesthesia in both groups will be documented (toxicity, blood in catheter, infection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-plane Group | Active Comparator | In this Group the femoral nerve catheter will be placed with the in-plane technique. |
|
| Out-of-plane Group | Active Comparator | In this Group the femoral nerve catheter will be placed with the out-of-plane technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In-plane Group | Procedure | Placement of femoral nerve catheter under ultrasound control |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dislocation of the femoral nerve catheter at 48 hours after its placement. | The catheter will be checked if in the right place using ultrasound location | 48 hours after the placement of the catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Time to place the catheter | Time to place the catheter measured in seconds | 30min (time needed to place and fix a femoral catheter) |
| satisfaction of the patient | satisfaction of the Patient during the block procedure in a scale of 0 to 10 (0 being not satisfied at all and 10 being totally satisfied) |
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Inclusion Criteria:
American Society of Anesthesiologists class I-III patients, both sexes
≥ 18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Urs Eichenberger, Prof. Dr. med. | Department of Anaesthesia, Intensive Care and Pain Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balgrist University Hospital | Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32453168 | Derived | Kalimeris K, Rupnik B, Allenspach K, Fucentese SF, Gotschi T, Aguirre J, Eichenberger U. Dislocation rates of perineural catheters placed either perpendicular or parallel to the femoral nerve: A randomised controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):758-764. doi: 10.1097/EJA.0000000000001237. |
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1 Group will be compared to another
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The Patient will not be told in which Group he belongs
| Out-of-plane Group | Procedure | Placement of femoral nerve catheter under ultrasound control |
|
| 48 hours after the placement of the catheter |
| number of failed blocks | number of failed blocks needed to be repeated | 30min (time needed to place and fix a femoral catheter and regognize if it works) |
| difficulty placing the catheter | difficulty placing the catheter under ultrasound control | 30min (time needed to place and fix a femoral catheter and to decide if it was difficult) |
| Effect of the femoral catheter on the sensory sensation | cold (cold metal bar) and pinprick (atraumatic test, using a sharp tip): can the patient recognize cold and sharp during the femoral nerve block? Answers are yes or no. | at 24 hours and 48 hours after the femoral nerve catheter |
| rescue boli given over the catheter in the 48 hours after its placement | amount of local anaesthetic rescue boli given | At 48 hours after the placement of the catheter |
| Dislocation of the femoral nerve catheter at 24 hours after its placement. | amount of catheter dislocations | At 24 and at 48 hours after the placement of the catheter |