AnalgesiaPhase 4INDEXNCT04394481

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

A Phase 4 study testing Dexmedetomidine, Ropivacaine and Dexamethasone in people with Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Analgesia
What is being tested?: Dexmedetomidine, Ropivacaine and Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 122 participants
Where: 1 siteFrance
Study dates: 28 Sep 2020to 11 Dec 2021
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital privé jean Mermoz
Lyon

Other trials in France

About this study

Official 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

Read the 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.

Conditions: Analgesia
Being tested: Dexmedetomidine, Ropivacaine, Dexamethasone
Medical subject headings: Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexmedetomidineDrug
IV injection (1 µg/kg - 100 mL) before anesthetic induction
RopivacaineDrug
Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
DexamethasoneDrug
IV injection (0.15 mg/kg) during anesthetic induction

Study groups in NCT04394481
Study group	Role	What they receive
DMD	Experimental	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg) Receives: Drug: Dexmedetomidine; Drug: Ropivacaine; Drug: Dexamethasone
Control	Active comparator	Ropivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Receives: Drug: Ropivacaine; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 96 hours

Secondary outcomes (6)

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
Measured: 96 hours
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
Measured: 96 hours
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)
Measured: 48 hours
Oral opioid analgesics
Cumulative amount of oral opioid analgesics taken during the 48 hours post-operative
Measured: 48 hours
Safety analysis
Evaluation of adverse events
Measured: 96 hours
4-level Likert scale
Patient satisfaction with regard to analgesia.
Measured: 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 202011 Dec 2021

First posted19 May 2020
Study start28 Sep 2020
Primary completion11 Dec 2021
Study completion11 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AnalgesiaStudies of the same condition, open and under way.
More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 122 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04394481
Sponsor's protocol ID: 2020-000611-74
Acronym: INDEX
Status last verified: Jan 2022
First submitted: 14 May 2020
Last updated: 4 Jan 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT04394481
Acronym / sponsor ID: INDEX / 2020-000611-74
Conditions: Analgesia
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 122 participants (actual)
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
Collaborators: Euraxi Pharma
Study start: 28 Sep 2020 (actual)
Primary completion: 11 Dec 2021 (actual)
Study completion: 11 Dec 2021 (actual)
First posted: 19 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
DMD	Experimental	Drug: Dexmedetomidine, Drug: Ropivacaine, Drug: DexamethasoneRopivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection Dexmedetomidine: IV injection (1µg/kg)
Control	Active comparator	Drug: Ropivacaine, Drug: DexamethasoneRopivacaine: perinervous injection (interscalene block) Dexamethasone: IV injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (8 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexmedetomidineIV injection (1 µg/kg - 100 mL) before anesthetic induction	Drug	DMD
RopivacainePerinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)	Drug	Control, DMD
DexamethasoneIV injection (0.15 mg/kg) during anesthetic induction	Drug	Control, DMD

Primary outcome

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.

6 secondary outcomes

Duration of the motor block
Time frame: 96 hours
Duration of the sensitive block
Time frame: 96 hours
Numerical scale from 0 to 10
Time frame: 48 hours
Oral opioid analgesics
Time frame: 48 hours
Safety analysis
Time frame: 96 hours
4-level Likert scale
Time frame: 96 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
Individual participant dataSharing planned: No

Related trials for Analgesia

RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
Not yet recruitingPhase 2
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julien CABATON principal investigator

Scientific Committee

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dexmedetomidine, Ropivacaine and Dexamethasone in people with Analgesia, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of dexmedetomidine in prolonging analgesia (time frame: 96 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04394481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.