Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

Study Overview
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Brief Summary
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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.

Official Title
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Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

Conditions
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Hip Replacement Arthroplasty

Intervention / Treatment
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* Procedure: Continuous lumbar plexus: stimulating catheter
* Procedure: Spinal Anesthesia
* Procedure: Local anesthetic infusion
* Procedure: Intravenous analgesia
* Procedure: Opioids rescue analgesia
* Drug: Mepivacaine 1%
* Drug: Levobupivacaine 0,5%
* Drug: Ropivacaine 0,2%
* Drug: Ketorolac 30mg
* Drug: Buprenorphine 0,2mg
* Device: Stimulong, Pajunk, Germany.
* Procedure: Continuous lumbar plexus: non-stimulating catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients undergoing total hip arthroplasty Exclusion Criteria: diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulating catheter<br>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. | Procedure: Continuous lumbar plexus: stimulating catheter<br>* 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.<br>Procedure: Spinal Anesthesia<br>* Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.<br>Procedure: Local anesthetic infusion<br>* 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<br>Procedure: Intravenous analgesia<br>* Ketorolac 30mg 3 times a day<br>Procedure: Opioids rescue analgesia<br>* Buprenorphine 0,2mg twice a day if VAS>4<br>Drug: Mepivacaine 1%<br> <br> Drug: Levobupivacaine 0,5%<br> <br> Drug: Ropivacaine 0,2%<br> <br> Drug: Ketorolac 30mg<br> <br> Drug: Buprenorphine 0,2mg<br> <br> Device: Stimulong, Pajunk, Germany.<br> <br> |
| Active Comparator: Non-stimulating catheter<br>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. | Procedure: Spinal Anesthesia<br>* Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.<br>Procedure: Local anesthetic infusion<br>* 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<br>Procedure: Intravenous analgesia<br>* Ketorolac 30mg 3 times a day<br>Procedure: Opioids rescue analgesia<br>* Buprenorphine 0,2mg twice a day if VAS>4<br>Drug: Mepivacaine 1%<br> <br> Drug: Levobupivacaine 0,5%<br> <br> Drug: Ropivacaine 0,2%<br> <br> Drug: Ketorolac 30mg<br> <br> Drug: Buprenorphine 0,2mg<br> <br> Device: Stimulong, Pajunk, Germany.<br> <br> Procedure: Continuous lumbar plexus: non-stimulating catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local anesthetic consumption | Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours. | 72h | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |