Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04394481
Other study ID # 2020-000611-74
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 28, 2020
Est. completion date December 11, 2021

Study information

Verified date January 2022
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date December 11, 2021
Est. primary completion date December 11, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
IV injection (1 µg/kg - 100 mL) before anesthetic induction
Ropivacaine
Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
Dexamethasone
IV injection (0.15 mg/kg) during anesthetic induction

Locations

Country Name City State
France Hôpital privé jean Mermoz Lyon

Sponsors (2)

Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche Euraxi Pharma

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 96 hours
Secondary 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 96 hours
Secondary 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) 48 hours
Secondary Oral opioid analgesics Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative 48 hours
Secondary Safety analysis Evaluation of adverse events 96 hours
Secondary 4-level Likert scale Patient satisfaction with regard to analgesia. 96 hours
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Suspended NCT04860635 - Safety of F14 Following Total Knee Replacement Phase 2/Phase 3
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A