Overview
Sponsor-declared trial summary
Patients scheduled for shoulder operations
To look at the efficacy of different doses of perineural dexmedetomidine to prolong the length of the analgetic block after a interscalene plexus block.
Key facts
- Sponsor
- Algemeen ziekenhuis Rivierenland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 2 Jan 2024 → 20 Jun 2025
- Decision date (initial)
- 2023-11-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To look at the efficacy of different doses of perineural dexmedetomidine to prolong the length of the analgetic block after a interscalene plexus block.
Secondary objectives 2
- To look at the possible side effects of higher doses of perineural dexmedetomidine ( hypotension and bradycardia )
- To look at the potential benefits of adding dexmedetomidine ( less opioid consumption, better patient satisfaction, less postoperative nausea and vomiting, better sleep )
Conditions and MedDRA coding
Patients scheduled for shoulder operations
Regulatory references
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504365-23-00 | Comparison of different doses of perineural dexmedetomidine as adjuvans to ropivacaine 0,67% for interscalene plexus block in association with 10 mg intravenous dexamethasone: a single center, double blinded, randomised controlled trial. | Algemeen ziekenhuis Rivierenland |
| 2023-506062-31-00 | Comparison of different doses of perineural dexmedetomidine as adjuvans to ropivacaine 0,67% for interscalene plexus block in association with 10 mg intravenous dexamethasone: a single center, double blinded, randomised controlled trial. | Algemeen ziekenhuis Rivierenland |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients scheduled for elective shoulder surgery
Exclusion criteria 13
- Chronic pain
- pregnancy
- Emergency operations
- No informed consent
- Medical history of cardial, renal or hepatic failure
- Ethylisme
- Cachexia
- Dehydratation
- Neurologic deficits or neuropathia of the brachial plexus
- Contra-indications for peripheral nerve block
- Allergy for ropivacaine, dexmedetomidine or dexamethasone
- > 80 years old
- second degree AV block
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Length of analgesia ( time untill intake of analgeticum )
Secondary endpoints 7
- Lenght of sensoric block
- Length of motoric block
- Percentage of postoperative nausea and vomiting first 48 hours
- Time to recovery after anesthesia
- Percentage of side effects during anesthesia ( hypotension, bradycardia )
- Numeric Rating Scale score for pain the first 48 hours
- Cumulative opioid consumption over 48 hours
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Dexdor 100 micrograms/ml concentrate for solution for infusion
PRD3495425 · Product
- Active substance
- Dexmedetomidine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 0.20 mg milligram(s)
- Max total dose
- 0.20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N05CM18 — -
- Marketing authorisation
- EU/1/11/718/001
- MA holder
- ORION CORPORATION
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Natriumklorid B. Braun 9 mg/ml innrennslislyf, lausn
PRD2083815 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 18 mg milligram(s)
- Max total dose
- 18 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- IS/1/09/171/01
- MA holder
- B.BRAUN MELSUNGEN AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
Dexamethason CF 20 mg/ml, injectievloeistof
PRD502494 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- RVG 55091
- MA holder
- CENTRAFARM B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ropivacaine 7.5 mg / ml solution for injection
PRD10150620 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 135 mg milligram(s)
- Max total dose
- 135 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- PL 48651/0005
- MA holder
- SINTETICA GMBH
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Algemeen ziekenhuis Rivierenland
- Sponsor organisation
- Algemeen ziekenhuis Rivierenland
- Address
- 's herenbaan 172
- City
- Rumst
- Postcode
- 2840
- Country
- Belgium
Scientific contact point
- Organisation
- Algemeen ziekenhuis Rivierenland
- Contact name
- herve vanden eede
Public contact point
- Organisation
- Algemeen ziekenhuis Rivierenland
- Contact name
- herve vanden eede
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 260 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2024-01-02 | 2024-01-09 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-30 | Belgium | Acceptable 2023-10-23
|
2023-11-09 |