Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
Phase 4
Completed
- Conditions
- Hip Replacement Arthroplasty
- Interventions
- Procedure: Spinal AnesthesiaProcedure: Local anesthetic infusionProcedure: Intravenous analgesiaProcedure: Opioids rescue analgesiaDevice: Stimulong, Pajunk, Germany.
- Registration Number
- NCT02162121
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- patients undergoing total hip arthroplasty
Exclusion Criteria
- diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stimulating catheter Intravenous analgesia 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. Stimulating catheter Opioids rescue analgesia 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. Stimulating catheter Mepivacaine 1% 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. Stimulating catheter Spinal Anesthesia 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. Stimulating catheter Local anesthetic infusion 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. Stimulating catheter Stimulong, Pajunk, Germany. 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 Spinal Anesthesia 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. Non-stimulating catheter Local anesthetic infusion 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. Non-stimulating catheter Intravenous analgesia 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. Non-stimulating catheter Opioids rescue analgesia 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. Non-stimulating catheter Stimulong, Pajunk, Germany. 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. Stimulating catheter Ketorolac 30mg 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 Ropivacaine 0,2% 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. Non-stimulating catheter Ketorolac 30mg 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. Non-stimulating catheter Buprenorphine 0,2mg 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. Non-stimulating catheter Mepivacaine 1% 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. Stimulating catheter Levobupivacaine 0,5% 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 Levobupivacaine 0,5% 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. Stimulating catheter Ropivacaine 0,2% 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. Stimulating catheter Buprenorphine 0,2mg 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.
- Primary Outcome Measures
Name Time Method Local anesthetic consumption 72h Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
- Secondary Outcome Measures
Name Time Method Up and Go test 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
Quadriceps strength 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°.
postoperative nausea and vomiting (PONV) 72h postoperatively Evaluation of nausea and vomit incidence in postoperative period with scale 0 from 4
Needle redirections During catheter position During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.
Visual Analog scale (VAS) score 72h postoperatively Evaluation of VAS static and VAS dynamic during first 72 postoperative hours
Opioids request 72h postoperatively Opioids consumption will be recorded throughout 72 postoperative hours
Catheter insertion time During catheter positioning Time (minutes) needed for catheter placement
Trial Locations
- Locations (1)
Istituto ortopedico Gaetano Pini
🇮🇹Milan, Italy