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

Phase 4

Completed

• Conditions: Analgesia
• Interventions: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Dexamethasone

• Registration Number: NCT04394481
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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).

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 Timeline

• Study First Submitted: 2020-05-14
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-19
• Study Start: 2020-09-28
• Primary Completion: 2021-12-11
• Study Completion: 2021-12-11
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DMD	Dexmedetomidine	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
DMD	Ropivacaine	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
Control	Ropivacaine	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection
Control	Dexamethasone	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection
DMD	Dexamethasone	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)

Primary Outcome Measures

Name	Time	Method
Effectiveness of dexmedetomidine in prolonging analgesia	96 hours	Delay between the start of the loco regional anesthésia (Hour 0) and the first post-operative oral morphine intake.

Secondary Outcome Measures

Name	Time	Method
4-level Likert scale	96 hours	Patient satisfaction with regard to analgesia.
Duration of the sensitive block	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
Numerical scale from 0 to 10	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)
Safety analysis	96 hours	Evaluation of adverse events
Oral opioid analgesics	48 hours	Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative
Duration of the motor block	96 hours	Delay between Hour 0 (H0) and the moment when the patient can move his/her forearm and / or his/her arm again

Trial Locations

Locations (1)

Hôpital privé jean Mermoz; 🇫🇷 Lyon, France