Skip to main content
OpenTrials
Completed

NCT Number: NCT04394481

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital privé jean Mermoz

Lyon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Ropivacaine

Drug

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

Dexamethasone

Drug

IV injection (0.15 mg/kg) during anesthetic induction

Primary outcomes

  1. Effectiveness of dexmedetomidine in prolonging analgesia

    Time frame: 96 hours

    Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake.

Secondary outcomes

  1. Duration of the motor block

    Time frame: 96 hours

    Delay between Hour 0 (H0) and the moment when the patient can move his/her forearm and / or his/her arm again

  2. Duration of the sensitive block

    Time frame: 96 hours

    Delay between H0 and the moment when the patient claims to have started to experience paraesthesia on his/her shoulder after the operation

  3. Numerical scale from 0 to 10

    Time frame: 48 hours

    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)

  4. Oral opioid analgesics

    Time frame: 48 hours

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

  5. Safety analysis

    Time frame: 96 hours

    Evaluation of adverse events

  6. 4-level Likert scale

    Time frame: 96 hours

    Patient satisfaction with regard to analgesia.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study 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

Acronym: INDEX

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.