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

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ClinicalTrials.gov Identifier: NCT03493490
Recruitment Status : Recruiting
First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Information provided by (Responsible Party):
Oliver Kimberger, Medical University of Vienna

Brief 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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Analgesic Adverse Reaction Cruciate Ligament Rupture Drug: Neodolpasse Drug: Diclofenac Drug: Placebo Phase 4

Detailed Description:

The clinical study is planned as a double-blind, randomised, treatment-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.

Patients who meet the inclusion and exclusion criteria will be enrolled to the clinical study and receive an enrolment number. The enrolment number will be a 4-digit number where the leftmost position will be zero ("0"). Enrolled patients will receive enrolment numbers starting at 0001, 0002, and so forth.

Only patients who were successfully randomized after surgery will continue the study protocol. All other patients will be regarded as screening failures. Successfully randomized patients will receive two infusions over 60 - 90 minutes with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device and will be allowed on demand analgetics as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low.

Anaesthesia will be induced with propofol (1.0-2.5 mg/kg), remifentanil (1 mcg/kg over minimum of 30s) and rocuronium (0.6mg/kg) and subsequently maintained with remifentail (0.25 - 1 mcg/kg/min), and sevoflurane. During skin suture, 7.5 mg piritramid will be administered. No nitrous oxide will be administered.

No other narcotics, analgesics, or sedatives than those described herein will be allowed. In case the surgical procedure mandates the use of additional and/or other narcotics, analgesics, or sedatives it shall be up to the investigator to decide on further treatment. However, in such case the patient will not be randomized and will be regarded as screening failure.

Randomization of the study patient takes place post-surgery as soon as the patient is able to cooperate adequatey. Ability to cooperate is defined as successful VAS assessment. At this time point the patient will be randomized and assigned her/his final randomisation number. The final randomisation number will be a 4-digit number where the leftmost position indicating the type of knee surgery performed. Patient undergoing surgery for cruciate ligament repair will receive randomisation numbers starting at 1001, 1002, and so forth. Patients undergoing knee replacement surgery will receive randomisation numbers starting at 2001, 2002, and so forth.

The first infusion of the investigational medicinal product will be started immediately after randomization. PCA will be established as soon as possible after the start of the first infusion of the investigational medicinal product but not later than 30 min after the start of the first infusion of the investigational medicinal product. A one-way PCA device (Vygon PCA-System) will be used. The PCA system is independent from any power supply and therefore both safe and reliable. The PCA system contains 20 mg Hydal® (hydromorphone) in 50 mL solvent. The PCA system parameters are fixed to a single bolus volume of 0.5 mL thus delivering 0.2 mg hydromorphone per bolus which equates to 2.0 mg piritramide or 1.5 mg morphine. Lock-out period of the PCA system used is fixed to 5 min.

All bolus injections will be recorded and added to the cumulative analgesic doses delivered by PCA.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Neodolpasse

In the Neodolpasse® arm patients 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.

Neodolpasse® Infusion Solution combines 75 mg (250 mL) of the NSAID diclofenac with 30 mg of the muscle-relaxant orphenadrine.

Drug: Neodolpasse
Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Active Comparator: Diclofenac

In the Diclofenac arm patients 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.

The Infusion solution contains 75 mg (250 mL) of the NSAID diclofenac.

Drug: Diclofenac
Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.

Placebo Comparator: Placebo
In the Placebo arm patients receive two physiologic saline infusion (250 mL) over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
Drug: Placebo
Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.




Primary Outcome Measures :
  1. PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in numbers of boli as well as mg. [ Time Frame: within 24 hours ]
    amount of pca analgetic administered


Secondary Outcome Measures :
  1. 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). [ Time Frame: after 24 hours ]
    vas pain measured



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03493490


Contacts
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Contact: Oliver Kimberger, M.D. +43140400 ext 41035 study@kimberger.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Oliver Kimberger, MD PD    +4340400 ext 4100    study@kimberger.at   
Principal Investigator: Oliver Kimberger, MD PD         
Sponsors and Collaborators
Medical University of Vienna
Investigators
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Principal Investigator: Oliver Kimberger, M.D. Medical University of Vienna

Publications:
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Responsible Party: Oliver Kimberger, Deputy Head of Department of Anesthesiology, General Intensive Care and Pain Medicine, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT03493490     History of Changes
Other Study ID Numbers: NDOL-001-2016
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Oliver Kimberger, Medical University of Vienna:
Double-Blind Method
placebo-controlled
parallel-group
single-centre
exploratory clinical study
Additional relevant MeSH terms:
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Diclofenac
Pain, Postoperative
Rupture
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Wounds and Injuries
Orphenadrine
Pharmaceutical Solutions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Muscle Relaxants, Central
Neuromuscular Agents
Parasympatholytics
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists