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Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?

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ClinicalTrials.gov Identifier: NCT02162121
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Gianluca Cappelleri, ASST Gaetano Pini-CTO

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hip Replacement Arthroplasty 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 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
Study Start Date : May 2014
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: 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.

Procedure: Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.

Procedure: 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

Procedure: Intravenous analgesia
Ketorolac 30mg 3 times a day

Procedure: Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS>4

Drug: Mepivacaine 1%
Drug: Levobupivacaine 0,5%
Drug: Ropivacaine 0,2%
Drug: Ketorolac 30mg
Drug: Buprenorphine 0,2mg
Device: Stimulong, Pajunk, Germany.
Active Comparator: 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.
Procedure: Spinal Anesthesia
Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.

Procedure: 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

Procedure: Intravenous analgesia
Ketorolac 30mg 3 times a day

Procedure: Opioids rescue analgesia
Buprenorphine 0,2mg twice a day if VAS>4

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



Primary Outcome Measures :
  1. Local anesthetic consumption [ Time Frame: 72h ]
    Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.


Secondary Outcome Measures :
  1. Visual Analog scale (VAS) score [ Time Frame: 72h postoperatively ]
    Evaluation of VAS static and VAS dynamic during first 72 postoperative hours

  2. Up and Go test [ Time Frame: 4th postoperative day ]
    "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

  3. Opioids request [ Time Frame: 72h postoperatively ]
    Opioids consumption will be recorded throughout 72 postoperative hours

  4. Quadriceps strength [ Time Frame: preoperative and 24h, 48h, 72h postoperatively ]
    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°.

  5. postoperative nausea and vomiting (PONV) [ Time Frame: 72h postoperatively ]
    Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4

  6. Needle redirections [ Time Frame: During catheter position ]
    During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.

  7. Catheter insertion time [ Time Frame: During catheter positioning ]
    Time (minutes) needed for catheter placement



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing total hip arthroplasty

Exclusion Criteria:

  • diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162121


Locations
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Italy
Istituto ortopedico Gaetano Pini
Milan, Italy
Sponsors and Collaborators
ASST Gaetano Pini-CTO
Investigators
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Principal Investigator: Gianluca Cappelleri, M.D. ASST Gaetano Pini-CTO
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Responsible Party: Gianluca Cappelleri, Medical Doctor, ASST Gaetano Pini-CTO
ClinicalTrials.gov Identifier: NCT02162121    
Other Study ID Numbers: IOGPGC06-14
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Ketorolac
Buprenorphine
Anesthetics
Ropivacaine
Levobupivacaine
Mepivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Narcotic Antagonists
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action