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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2021-12-11

Brief Summary

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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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Detailed Description

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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.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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DMD

Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Ropivacaine

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

IV injection (0.15 mg/kg) during anesthetic induction

Control

Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

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

Dexamethasone

Intervention Type DRUG

IV injection (0.15 mg/kg) during anesthetic induction

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Ropivacaine

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

Intervention Type DRUG

Dexamethasone

IV injection (0.15 mg/kg) during anesthetic induction

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No