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| Name | Class |
|---|---|
| Euraxi Pharma | INDUSTRY |
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The main objective of the study is to demonstrate the efficacy of Dexmedetomidine on the prolongation of analgesia obtained by interscalenic bloc of the brachial plexus and intravenous injection of Dexamethasone (efficacy objective).
This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of This is an interventional, comparative, randomized, controlled study versus reference treatment, in 2 parallel groups, double blind (patient and evaluator), multicenter, aiming to demonstrate the superiority of Dexmedetomidine over the absence of Dexmedetomidine, in adjuvantation of a loco regional anesthesia (interscalenic bloc of the brachial plexus + intravenous injection of Dexamethasone), on the prolongation of the analgesia, following a surgery of the rotator cuff of the shoulder under arthroscopy.
Patients will be randomized into 2 groups according to the treatment received:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMD | Experimental | Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg) |
|
| Control | Active Comparator | Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | IV injection (1 µg/kg - 100 mL) before anesthetic induction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of dexmedetomidine in prolonging analgesia | Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake. | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the motor block | Delay between Hour 0 (H0) and the moment when the patient can move his/her forearm and / or his/her arm again | 96 hours |
| Duration of the sensitive block | Delay between H0 and the moment when the patient claims to have started to experience paraesthesia on his/her shoulder after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien CABATON | Scientific Committee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital privé jean Mermoz | Lyon | France |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ropivacaine |
| Drug |
Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL) |
|
| Dexamethasone | Drug | IV injection (0.15 mg/kg) during anesthetic induction |
|
| 96 hours |
| Numerical scale from 0 to 10 | Pain scores at rest and in motion estimated by the patient at Hour 4 (H4), Hour 12 (H12), Hour 24 (H24) and Hour 48 (H48) | 48 hours |
| Oral opioid analgesics | Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative | 48 hours |
| Safety analysis | Evaluation of adverse events | 96 hours |
| 4-level Likert scale | Patient satisfaction with regard to analgesia. | 96 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000813 |
| Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |