NCT04394481

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Analgesia

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	IV injection (1 µg/kg - 100 mL) before anesthetic induction
DRUG	Ropivacaine	Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
DRUG	Dexamethasone	IV injection (0.15 mg/kg) during anesthetic induction

Timeline

• Start date: 2020-09-28
• Primary completion: 2021-12-11
• Completion: 2021-12-11
• First posted: 2020-05-19
• Last updated: 2022-01-04

Locations

1 site across 1 country: France