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Saphenus blok reduceerd opname duur na epifysiodese van de knie - een triple blind superiority trial


- candidate number29098
- NTR NumberNTR7320
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jul-2018
- Secondary IDsNL64631.042.18 
- Public TitleSaphenus blok reduceerd opname duur na epifysiodese van de knie - een triple blind superiority trial
- Scientific TitleSaphenoUs Nerve block Reduces length of Stay after Epiphysiodesis of the knee-a triple blind randomized superiority trial
- ACRONYM
- hypothesisWe hypothesize that a single shot saphenous nerve block in combination with general anesthesia would be superior to general anesthesia alone regarding opiod consumption. pain scores. recovery and length of stay in adolecent patients undergoing epiphysiodesis of the knee.
- Healt Condition(s) or Problem(s) studiedSaphenous nerve block, Epiphysiodesis
- Inclusion criteria12-18 yaers of age
ASA 1 of 2
bilateral epiphysiodesis planned
informed consent
- Exclusion criteriaASA 3 or higher
chronic pain
chronic use of opiods
refusal of the patient or care taker
allergy to Ropivacaine
abnormallity of the pheripheral nervous system concerning the femoral nerve and/ or the saphenous nerve
inflammation of the distal third of the thigh
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingTriple
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 2-sep-2018
- planned closingdate28-feb-2020
- Target number of participants0
- InterventionsSingle shot saphenous nerve block with either Ropivacaine or sodium chloride
- Primary outcomelenght of stay after surgery
- Secondary outcomeintra- and postoperative opiod consumption
NRS pain scores
time in the post anesthetic care unit
time to walk (with crutches)
strength of the quadriceps muscle
overall patient satisfaction
- TimepointsNRS three time a day
strength of quadriceps msucle twice a day postoperatieve day 1 and 2
overall patient satisfaction day after discharge
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Wilhelmina Ziekenhuis Assen Poli anesthesiologie
- CONTACT for SCIENTIFIC QUERIESDr. C.A. Abusaris
- Sponsor/Initiator Wilhelmina Ziekenhuis Assen (WZA)
- Funding
(Source(s) of Monetary or Material Support)
Fund = Initiator = Sponsor
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD2-jul-2018 - 9-jul-2018


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