Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
NCT ID: NCT02162121
Last Updated: 2017-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
64 participants
INTERVENTIONAL
2014-05-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stimulating catheter
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.
Continuous lumbar plexus: stimulating catheter
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.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
Local anesthetic infusion
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
Ketorolac 30mg 3 times a day
Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS\>4
Mepivacaine 1%
Levobupivacaine 0,5%
Ropivacaine 0,2%
Ketorolac 30mg
Buprenorphine 0,2mg
Stimulong, Pajunk, Germany.
Non-stimulating catheter
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.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
Local anesthetic infusion
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
Ketorolac 30mg 3 times a day
Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS\>4
Mepivacaine 1%
Levobupivacaine 0,5%
Ropivacaine 0,2%
Ketorolac 30mg
Buprenorphine 0,2mg
Stimulong, Pajunk, Germany.
Continuous lumbar plexus: non-stimulating catheter
Interventions
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Continuous lumbar plexus: stimulating catheter
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.
Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
Local anesthetic infusion
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
Ketorolac 30mg 3 times a day
Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS\>4
Mepivacaine 1%
Levobupivacaine 0,5%
Ropivacaine 0,2%
Ketorolac 30mg
Buprenorphine 0,2mg
Stimulong, Pajunk, Germany.
Continuous lumbar plexus: non-stimulating catheter
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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ASST Gaetano Pini-CTO
OTHER
Responsible Party
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Gianluca Cappelleri
Medical Doctor
Principal Investigators
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Gianluca Cappelleri, M.D.
Role: PRINCIPAL_INVESTIGATOR
ASST Gaetano Pini-CTO
Locations
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Istituto ortopedico Gaetano Pini
Milan, , Italy
Countries
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Other Identifiers
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IOGPGC06-14
Identifier Type: -
Identifier Source: org_study_id
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