A Phase 4 interventional study of Continuous lumbar plexus: stimulating catheter and Spinal Anesthesia in Hip Replacement Arthroplasty, sponsored by ASST Gaetano Pini-CTO. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-08-14.
Sponsored by ASST Gaetano Pini-CTO · Phase 4, Interventional, and Treatment
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.
ASST Gaetano Pini-CTO is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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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 · 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.
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 · 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
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 will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
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
Ketorolac 30mg 3 times a day
Buprenorphine 0,2mg twice a day if VAS\>4
Local anesthetic consumption
Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
Time frame: 72h
Visual Analog scale (VAS) score
Evaluation of VAS static and VAS dynamic during first 72 postoperative hours
Time frame: 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
Time frame: 4th postoperative day
Opioids request
Opioids consumption will be recorded throughout 72 postoperative hours
Time frame: 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°.
Time frame: 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
Time frame: 72h postoperatively
Needle redirections
During catheter positioning number of needle redirections necessary to found lumbar plexus are recorder.
Time frame: During catheter position
Catheter insertion time
Time (minutes) needed for catheter placement
Time frame: During catheter positioning
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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ASST Gaetano Pini-CTO