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

GCS Ramsay Santé pour l'Enseignement et la Recherche122 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Analgesia

Interventions

DexmedetomidineDRUG

IV injection (1 µg/kg - 100 mL) before anesthetic induction

RopivacaineDRUG

Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)

DexamethasoneDRUG

IV injection (0.15 mg/kg) during anesthetic induction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hôpital privé jean Mermoz

Lyon, France

Outcomes

Primary Outcomes

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.

Time frame: 96 hours

Secondary Outcomes

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

Time frame: 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

Time frame: 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)

Time frame: 48 hours

Oral opioid analgesics

Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative

Time frame: 48 hours

Safety analysis

Evaluation of adverse events

Time frame: 96 hours

4-level Likert scale

Patient satisfaction with regard to analgesia.

Time frame: 96 hours

Data from ClinicalTrials.gov

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