E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dexmedetomidine -a selective alpha-2-receptor agonist- added to a local anaesthetic (ropivacaine) should prolong a saphenous block and the patients demand for the first analgesic. We designed a prospective, controlled, randomized, triple-blinded study with 40 patients parted into 2 groups who have to undergo anterior cruciate ligament reconstruction. Group R receives 10ml Ropivacaine 7.5mg/ml, group R%100DEX receives 10ml Ropivacaine 7,5mg/ml with 100µg Dexmedetomidine. |
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E.1.1.1 | Medical condition in easily understood language |
Dexmedetomidine, a drug for sedation, added to a local anaesthesia should prolong a blockade and the demand for first analgesic in patients after anterior cruciate ligament reonstruction. |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to evaluate the clinical use of 100µg dexmedetomidine (a selective alpha-2-receptor agonistic drug) as an adjuvant to ropivacaine for saphenous nerve blockade.
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E.2.2 | Secondary objectives of the trial |
We will describe the effects of dexmedetomidine on use of analgesics and will evaluate its side effects when used for saphenous nerve blockade. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Study patients between 16 and 60 years - ASA physical status 1-2 - BMI < 30 kg/m2 - Scheduled for posttraumatic ACLR - Written informed consent given by study patients after being provided with detailed information about the nature, risks, and scope of the clinical study as well as the expected desirable and adverse effects of the drugs - No legal incapacity and/or other circumstances rendering the study patients unable to understand the nature, scope and possible consequences of the study
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E.4 | Principal exclusion criteria |
natomical abnormalities of the respective lower extremity identified by physical examination or ultrasound
- Known allergy or hypersensitivity to ropivacaine or other amino-amide LA
- Known allergy or hypersensitivity to dexmedetomidine
- Participation in another clinical study within the last 4 weeks prior to study
- Coagulopathy
- Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and hypertension with a systolic BP > 180 mmHg) during evaluation of eligibility for study participation
- Coronary heart disease with an CCS III and higher
- Chronic heart failure NYHA III and higher
- Chronic opioid consumption exceeding a morphine-equivalent dose of 15mg per day
- Bradycardia with a heart rate after 5 min resting of < 40 b/min
- Abnormalities in ECG that are considered clinically relevant like AV-block 2nd degree and higher
- Unreliability and/or lack of cooperation
- Other objections to participate in the study in the opinion of the investigator
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E.5 End points |
E.5.1 | Primary end point(s) |
duration of sensory block defined by demand for first analgesic |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Prior the block, 2 min, 4 min, 6 min, 8 min, 10 min, 15 min, 20 min, 30 min. No Pinprick-related sensory evaluation will be performed during and after surgery. |
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E.5.2 | Secondary end point(s) |
- Successful blockade of the saphenous nerve block determined by pin-prick testing in the area of sensory supply (medial malleolus)
- Onset time of sensory block
- Haemodynamic parameters (mean arterial blood pressure, heart rate)
- State of vigilance defined by the Richmond Agitation and Sedation Score (RASS)
- Plasma levels of dexmedetomidine (30, 90 and 180 minutes after blockade) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Block success: sensory onset time ≤ 60 min (when all above defined parts of the saphenous nerve show a Pinprick ≤ 10% compared to contralateral side)
- Duration of sensory block: time period from performance of saphenous nerve block to first analgesic demand (by i.v. PCA self-administration)
- Time until maximum sedation level: time from performance of saphenous nerve block to maximum sedation level (RASS score) Duration of sedation: Time from RASS score = -1 until RASS score = 0 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Postoperatively patients will come to Postoperative Care Unit and will receive a patient controlled analgesia (PCA) infusion pump. Patients will be discharged from the postoperative ward according to the following criteria: RASS score = 0 Within one week after the study day, study patients will be finally investigated regarding clinical signs of nerve damage (full recovery of the nerve block) and inflammation or infection of the puncture area.
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |