Pain, Postoperative Clinical Trial
Official title:
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.
Verified date | March 2023 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 72 |
Est. completion date | May 31, 2019 |
Est. primary completion date | May 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University of Vienna | Vienna |
Lead Sponsor | Collaborator |
---|---|
Medical University of Vienna |
Austria,
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. — View Citation
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. — View Citation
Kehlet H. Synergism between analgesics. Ann Med. 1995 Apr;27(2):259-62. doi: 10.3109/07853899509031968. — View Citation
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. — View Citation
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. Erratum In: Crit Care Med. 2010 Jun;38(6):1509. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg | amount of pca analgetic administered | within 24 hours | |
Secondary | VAS-Scale: Pain relief will be tracked during the infusion periods and until 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS). | visual analogue scales (VAS) pain measured The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain pain severity. The VAS used is a straight horizontal line of fixed length 100 mm and pople scored their Pain 0-100. | after 24 hours |
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