Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Extension of the Analgesia of an Interscalene Block of the Brachial Plexus by Combined Injection of Dexamethasone and Dexmedetomidine, After Arthroscopic Shoulder Surgery: Randomized, Controlled, Double-blind Trial

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Ropivacaine
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMD<br>Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg) | Drug: Dexmedetomidine<br>* IV injection (1 µg/kg - 100 mL) before anesthetic induction<br>Drug: Ropivacaine<br>* Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)<br>Drug: Dexamethasone<br>* IV injection (0.15 mg/kg) during anesthetic induction<br>|
| Active Comparator: Control<br>Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection | Drug: Ropivacaine<br>* Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)<br>Drug: Dexamethasone<br>* IV injection (0.15 mg/kg) during anesthetic induction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |