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Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stimulating catheter | Experimental | After Spinal Anesthesia (Levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15 ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. |
|
| Non-stimulating catheter | Active Comparator | After Spinal Anesthesia (levobupivacaine 0,5% 15mg) all patients in the arm will receive continuous lumbar plexus block with non-stimulating catheter ("Stimolong", "Pajunk", Germany). Mepivacaine 1% 15ml will be administrated. As post-operative analgesia Ropivacaine 0,2% will be continuous administrated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous lumbar plexus: stimulating catheter | Procedure | Perinervous stimulating catheter ("Stimulong", "Pajunk", Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Local anesthetic consumption | Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours. | 72h |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog scale (VAS) score | Evaluation of VAS static and VAS dynamic during first 72 postoperative hours | 72h postoperatively |
| Up and Go test | "up and go" test: time need to get up from a chair, walk for 3 meters, and come back to seat down on the chair |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Cappelleri, M.D. | ASST Gaetano Pini-CTO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto ortopedico Gaetano Pini | Milan | Italy |
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| Spinal Anesthesia | Procedure | Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected. |
|
| Local anesthetic infusion | Procedure | Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day |
|
| Intravenous analgesia | Procedure | Ketorolac 30mg 3 times a day |
|
| Opioids rescue analgesia | Procedure | Buprenorphine 0,2mg twice a day if VAS>4 |
|
| Mepivacaine 1% | Drug |
|
| Levobupivacaine 0,5% | Drug |
|
| Ropivacaine 0,2% | Drug |
|
| Ketorolac 30mg | Drug |
|
| Buprenorphine 0,2mg | Drug |
|
| Stimulong, Pajunk, Germany. | Device |
|
| Continuous lumbar plexus: non-stimulating catheter | Procedure |
|
| 4th postoperative day |
| Opioids request | Opioids consumption will be recorded throughout 72 postoperative hours | 72h postoperatively |
| Quadriceps strength | evaluate bilateral muscle strength with an isometric force dynamometer to measure the force produced during a maximum voluntary isometric contraction in a lying position by the knee flex to 90°. | preoperative and 24h, 48h, 72h postoperatively |
| postoperative nausea and vomiting (PONV) | Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4 | 72h postoperatively |
| Needle redirections | During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder. | During catheter position |
| Catheter insertion time | Time (minutes) needed for catheter placement | During catheter positioning |
| ID | Term |
|---|---|
| D000775 | Anesthesia, Spinal |
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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