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

NCT04394481 | Completed Phase 4

• 1 other identifier: 2020-000611-74
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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 Dexamethasone (efficacy objective).

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Duration of the motor block

  96 hours

• Duration of the sensitive block

  96 hours

• Numerical scale from 0 to 10

  48 hours

• Oral opioid analgesics

  48 hours

• Safety analysis

  96 hours

Study Arms (2)

DMD

EXPERIMENTAL

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

Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Dexamethasone

Control

ACTIVE COMPARATOR

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

Drug: Ropivacaine; Drug: Dexamethasone

Interventions

Dexmedetomidine DRUG

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

DMD

Ropivacaine DRUG

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

Control; DMD

Dexamethasone DRUG

IV injection (0.15 mg/kg) during anesthetic induction

Control; DMD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital privé jean Mermoz

Lyon, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Julien CABATON

  Scientific Committee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: May 19, 2020
• Study Start: September 28, 2020
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: January 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)