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

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

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).

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Hopital Prive Jean Mermoz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DMD; Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)	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
Active Comparator: Control; Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma
• Investigators: Principal Investigator: Julien CABATON, Scientific Committee

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): December 11, 2021
• Study Completion (Actual): December 11, 2021

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: January 3, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexamethasone; Dexmedetomidine; Ropivacaine
• Other Study ID Numbers: 2020-000611-74

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No