Hôpital privé jean Mermoz
Lyon, France
NCT Number: NCT04394481
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Lyon, France
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV injection (1 µg/kg - 100 mL) before anesthetic induction
Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
IV injection (0.15 mg/kg) during anesthetic induction
Time frame: 96 hours
Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake.
Time frame: 96 hours
Delay between Hour 0 (H0) and the moment when the patient can move his/her forearm and / or his/her arm again
Time frame: 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
Time frame: 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)
Time frame: 48 hours
Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative
Time frame: 96 hours
Evaluation of adverse events
Time frame: 96 hours
Patient satisfaction with regard to analgesia.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
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
Acronym: INDEX
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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