Saftey and efficacy of two different doses of Neramexane mesylate as preemptive analgesic and add-on therapy to opioids in the management of postoperative pain. A randomised, double-blind, placebo-controlled, sequential, dose-escalating, multicentre study. - pre-emptive Analgesie

Merz Pharmaceuticals GmbH0 个研究点开始时间: 2005年2月4日最近更新: 2012年3月19日

适应症

试验速览

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•Male or female patients between 18 and 70 years of age at baseline
•Planned surgery for arthroscopic unilateral anterior cruciate ligament repair using patellar or hamstring autograft technique
•Traumatic lesion of the anterior cruciate ligament at least 1 month prior to surgery
•Planned patient controlled analgesia with application of opioids during the first 48 postoperative hours
•ASA class I or II
•Planned general anaesthesia following a standardised procedure using sufentanil, thiopental, midazolam, and atracurium, supplemented by halothane/nitrous oxide.
•Signed Informed Consent
•Patient is capable to understand the nature of the study and the procedures to be followed including use of PCA
•Patient is expected to comply with the scheduled visits and dosing scheme
•For further details please refer to Clinical Trial Protocol MRZ 92579-0404/1, chapter 9.3.1.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Planned intra-articular administration of analgesics or local anaesthetics during surgery
•History of chronic pain with chronic use of analgesics during the last 6 months
•Planned use of any analgesics within 48 hours prior to surgery
•Patients with systemic and/or serious coexisting diseases, such as malignancy (other than excised basal cell carcinoma), or any clinically significant haematological, endocrine (other than euthyroid struma or diabetes sufficiently treated with oral antidiabetics), cardiovascular (including any rhythm disorder), renal, hepatic, gastrointestinal or neurological (including any form of epilepsy) disease
•Patients with clinical relevant abnormal ECG findings
•Potassium = 5.6 mmol/l
•Patients with systolic blood pressure greater than 160 mm Hg or less than 90 mm Hg or diastolic blood pressure greater than 100 mm Hg or less than 50 mm Hg at the screening or baseline visit with or without stable antihypertensive medication
•Patients with orthostatic dysregulation
•Patients with known allergy, hypersensitivity, or intolerance to Neramexane, amantadine, ketamine, or memantine
•Women who are pregnant or breast feeding
•For further details please refer to Clinical Trial Protocol MRZ 92579-0404/1, chapter 9.3.2.

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