NCT02162121|CompletedPhase 4
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Sponsor study identifier
interventional
64
1 country
1
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
June 9, 2014
Actual (reported)June 12, 2014
Actual (reported)October 2016
Actual (reported)October 2016
Actual (reported)Local anesthetic consumption
Evaluation of local anesthesic consumption every 6h in first 72 postoperative hours.
72h
Visual Analog scale (VAS) score
72h postoperatively
Up and Go test
4th postoperative day
Opioids request
72h postoperatively
Quadriceps strength
preoperative and 24h, 48h, 72h postoperatively
postoperative nausea and vomiting (PONV)
72h postoperatively
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.
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.
Istituto ortopedico Gaetano Pini
Milan, Italy
Gianluca Cappelleri, M.D.
ASST Gaetano Pini-CTO
64 participants (actual enrollment reported by the registry).
First Submitted
June 9, 2014
First Posted
June 12, 2014
Study Start
May 2014
Date type not reportedThis date has not been verified as actual or estimated.
Comparison Between Two Techniques of Volemic Expansion in Hip Replacement Arthroplasty
Total Knee Prosthesis With Continuous Block of Adductor Canal and Outcome
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.
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
Contact the study team to confirm eligibility.
Primary Completion
October 2016
Actual (reported)Study Completion
October 2016
Actual (reported)Last Updated
August 14, 2017
Record last verified: 2017-08
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Source: ClinicalTrials.gov.
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