Analgesia
Conditions
Brief summary
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).
Detailed description
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: * Dexmedetomidine; * Nothing (control arm). The investigator (anesthesiologist) who will perform the randomization will not be blinded to the treatment.
Interventions
DRUGDexmedetomidine
IV injection (1 µg/kg - 100 mL) before anesthetic induction
DRUGRopivacaine
Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
DRUGDexamethasone
IV injection (0.15 mg/kg) during anesthetic induction
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Patient undergoing arthroscopic shoulder surgery to repair the rotator cuff tendons; * Patient capable of understanding the information related to the study, of reading the information leaflet and agreeing to sign the consent form.
Exclusion criteria
* Patient on oral morphines before surgery; * Contraindication to performing a general anesthesia associated with a shoulder loco regional anesthesia in a single injection; * Contraindication to take oral morphines; * Any non-arthroscopic repair (intraoperative conversion to open sky technique); * Any other loco regional anesthesia than an interscalenic block (change of intraoperative strategy); * Pregnant or lactating woman; * Intolerance or allergy or contraindication to one of the treatments under study; * Patient participating in another clinical trial, or in a period of exclusion from another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of dexmedetomidine in prolonging analgesia | 96 hours | Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the sensitive block | 96 hours | Delay between H0 and the moment when the patient claims to have started to experience paraesthesia on his/her shoulder after the operation |
| Numerical scale from 0 to 10 | 48 hours | 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) |
| Duration of the motor block | 96 hours | Delay between Hour 0 (H0) and the moment when the patient can move his/her forearm and / or his/her arm again |
| Safety analysis | 96 hours | Evaluation of adverse events |
| 4-level Likert scale | 96 hours | Patient satisfaction with regard to analgesia. |
| Oral opioid analgesics | 48 hours | Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative |
Countries
France
Outcome results
None listed