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

Analgesia Clinical Trial

— INDEX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04394481
• Other study ID #: 2020-000611-74
• Status: Completed
• Phase: Phase 4
• Start date: September 28, 2020
• Est. completion date: December 11, 2021

Study information

• Verified date: January 2022
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 11, 2021
• Est. primary completion date: December 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia

Intervention

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

Locations

Country	Name	City	State
France	Hôpital privé jean Mermoz	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche	Euraxi Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Oral opioid analgesics	Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative	48 hours
Secondary	Safety analysis	Evaluation of adverse events	96 hours
Secondary	4-level Likert scale	Patient satisfaction with regard to analgesia.	96 hours