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Effect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing


- candidate number18022
- NTR NumberNTR4628
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR3-jun-2014
- Secondary IDsNL34510.008.11  METC Brabant
- Public TitleEffect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing
- Scientific TitleEffect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing; a randomized controlled double blind crossover trial
- ACRONYMINCOP
- hypothesisAn infrapatellar nerve block with lidocaine alters anterior knee pain (measured on VAS) in patients 6 months after tibial nailing.
- Healt Condition(s) or Problem(s) studiedPain, Knee, Nerve block
- Inclusion criteria- Traumatic tibial shaft fracture treated with an intramedullary nail.
- Age between 18 and 65 (during trial).
- Mean VAS 4-6 during at least 3 out of 8 activities or VAS 7 or higher during 1 or more activities.
- Exclusion criteria- Preexistent knee pain or knee problems.
- Contraindication or intolerance for lidocaine.
- Insufficient comprehension of Dutch language.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 3-okt-2013
- planned closingdate11-sep-2017
- Target number of participants34
- InterventionsLidocaine Hydrochloride Injection 2%
Sodium Chloride Injection, USP 0.9%
- Primary outcomeDifference in anterior knee pain (VAS) for the most painful activity (measured at baseline) before and after infrapatellar nerve block with lidocaine and sodium chloride at least 6 months after intramedullary nailing
- Secondary outcomeAnterior knee pain (VAS) during 8 different activities at least 6 months after tibial nailing. Anterior knee pain (VAS) during 8 different activities at least 6 months after tibial nailing. Infrapatellar nerve injury at least 6 months after tibial nailing.
- TimepointsVAS for anterior kneepain is measured at baseline (at least 6 months after tibial nailing), after first and after second injection.
- Trial web site
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES M.S. Leliveld
- CONTACT for SCIENTIFIC QUERIES M.S. Leliveld
- Sponsor/Initiator Hospital Gelderse Vallei, St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
Hospital Gelderse Vallei Ede, St. Elisabeth Hospital Tilburg
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD3-jun-2014 - 11-nov-2017


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