Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery

Summary

The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.

Timeline

Start

2018-03-01

Primary completion

2019-05-31

Completion

2019-05-31

Publications

• Background Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001 Nov;13(7):524-39. doi: 10.1016/s0952-8180(01)00320-8.
• Background Kehlet H. Synergism between analgesics. Ann Med. 1995 Apr;27(2):259-62. doi: 10.3109/07853899509031968.
• Background Kornhuber J, Parsons CG, Hartmann S, Retz W, Kamolz S, Thome J, Riederer P. Orphenadrine is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist: binding and patch clamp studies. J Neural Transm Gen Sect. 1995;102(3):237-46. doi: 10.1007/BF01281158.
• Background Hunskaar S, Berge OG, Hole K. Orphenadrine citrate increases and prolongs the antinociceptive effects of paracetamol in mice. Acta Pharmacol Toxicol (Copenh). 1986 Jul;59(1):53-9. doi: 10.1111/j.1600-0773.1986.tb00134.x.
• Background Luetz A, Heymann A, Radtke FM, Chenitir C, Neuhaus U, Nachtigall I, von Dossow V, Marz S, Eggers V, Heinz A, Wernecke KD, Spies CD. Different assessment tools for intensive care unit delirium: which score to use? Crit Care Med. 2010 Feb;38(2):409-18. doi: 10.1097/CCM.0b013e3181cabb42.

Drugs

Indications