Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery - an Exploratory Placebo-controlled Clinical Study to Investigate the Analgesic Properties of the Combination of Diclofenac and Orphenadrine Versus Diclofenac Alone.

NDOL-001-2016

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.

2018-03-01

2019-05-31

2019-05-31

Completed

Early phase I

72

Inclusion Criteria: * Elective cruciate ligament surgery * Confirmed patient suitability for planned surgery * Legally valid signed written informed consent provided * Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding * Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients * No known intolerabilities or hypersensitivities to any part of the IMP / control medication * No reoperation/revision within 6 months after the initial surgery * Absence of history of abuse of analgesics or other drug * No analgesics within 48 hours prior to surgery (surgery-related medication excluded) * No current / recent (within 4 weeks prior to enrolment) experimental treatment * No current / recent (within 4 weeks prior to enrolment) participation in another clinical study * No foreseeable difficulties with regard to protocol compliance * No known hypersensibility against the active ingredients diclofenac, orphenadrine, remifentanil, propofol, rocuronium, and hydromorphone * No known hypersensibility against the other ingredients of the investigational medicinal product * Absence of congestive heart failure classes 2 or higher according to the NYHA classification * Absence of ischemic heart disease * Absence of peripheral arterial occlusive disease * Absence of cerebro-vascular disease * Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, type-2 diabetes, moderate smoking defined as consumation of 11 cigarettes or more per day) exclusion criteria * Major complications during surgery possibly leading to problems in the handling of the PCA or subsequently with the experimental treatment * Intolerable adverse events or any serious adverse event * Severe violation of the clinical study protocol * Withdrawal of patient informed consent

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization of the study patient takes place pre-surgery. Successfully randomized patients will receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low, also in the placebo group.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

2023-03-20