Clinical trial NCT04394481: Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2020-05-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of dexmedetomidine in prolonging analgesia
timeFrame: 96 hours
Secondary outcomes:
measure: Duration of the motor block
timeFrame: 96 hours
measure: Duration of the sensitive block
timeFrame: 96 hours
measure: Numerical scale from 0 to 10
timeFrame: 48 hours
measure: Oral opioid analgesics
timeFrame: 48 hours
measure: Safety analysis
timeFrame: 96 hours
measure: 4-level Likert scale
timeFrame: 96 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital privé jean Mermoz
Study officials:
affiliation: Scientific Committee
name: Julien CABATON
role: PRINCIPAL_INVESTIGATOR
References: