Status:
COMPLETED
Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Analgesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 De...
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 supe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2021
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04394481
Start Date
September 28 2020
End Date
December 11 2021
Last Update
January 4 2022
Active Locations (1)
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1
Hôpital privé jean Mermoz
Lyon, France