|- candidate number||18022|
|- NTR Number||NTR4628|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-jun-2014|
|- Secondary IDs||NL34510.008.11 METC Brabant|
|- Public Title||Effect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing|
|- Scientific Title||Effect of infrapatellar nerve block on chronic anterior knee pain after tibial nailing; a randomized controlled double blind crossover trial|
|- hypothesis||An 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) studied||Pain, 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||3-okt-2013|
|- planned closingdate||11-sep-2017|
|- Target number of participants||34|
|- Interventions||Lidocaine Hydrochloride Injection 2%|
Sodium Chloride Injection, USP 0.9%
|- Primary outcome||Difference 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 outcome||Anterior 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.
|- Timepoints||VAS for anterior kneepain is measured at baseline (at least 6 months after tibial nailing), after first and after second injection.|
|- Trial web site|
|- status||inclusion 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|
(Source(s) of Monetary or Material Support)
|Hospital Gelderse Vallei Ede, St. Elisabeth Hospital Tilburg|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||3-jun-2014 - 11-nov-2017|