Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
1,716
Countries
1
Sites
12
Distal radius fracture in need of acute closed reduction
To evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius fracture managed with closed reduction, compared to standard care.
Key facts
- Sponsor
- Region Hovedstaden
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 10 Dec 2024 → ongoing
- Decision date (initial)
- 2024-09-12
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sygeforsikringen “danmark” · The Independent Research Fund Denmark · The research foundation of The Capital Region of Denmark · The research foundation of Copenhagen University Hospital - North Zealand, Hillerød
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate the beneficial and harmful effects of an ultrasound-guided brachial plexus nerve block for patients with a distal radius fracture managed with closed reduction, compared to standard care.
Conditions and MedDRA coding
Distal radius fracture in need of acute closed reduction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Adults (age ≥ 18 years) with a distal radius fracture in need of closed reduction
Exclusion criteria 7
- Patients who would never qualify for surgery according to local guidelines
- Lack of informed consent
- No Danish Central Person Register (CPR) number
- Allergies to the trial medication
- Distal radius fracture initially deemed to require surgery regardless of the outcome of the closed reduction
- Open fracture (fracture-related wound requiring sutures), other fractures on the same extremity (NOT including distal ulna fracture(s)) or bilateral distal radius fractures both requiring closed reduction.
- Concomitant medical or surgical condition taking priority over the closed reduction of the distal radius fracture.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Cumulative proportion of patients with distal radius fracture surgery 90 days after closed reduction
Secondary endpoints 4
- Composite outcome of treatment related complications: loco-regional neurological complications from affected arm, local anaesthetic systemic toxicity, soft tissue injuries related to the closed reduction procedure, infection at the site of needle puncture, vessel puncture requiring subsequent treatment, pneumothorax, allergic reaction, new bone or joint injury after the closed reduction and/or pulmonary embolism witin 90 days after closed reducti
- Patient Rated Wrist Evaluation (PRWE) 90 days after closed reduction
- Maximum pain score (Numerical Rating Scale (NRS) 0-10) in the affected wrist during closed reduction(s)
- Proportion of patients with unacceptable radiographic fracture position immediately after closed reduction, according to AAOS guidelines
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Lidokain-adrenalin SAD, injektionsvæske, opløsning
PRD349048 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 7 mg/kg milligram(s)/kilogram
- Max total dose
- 7 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB52 — LIDOCAINE, COMBINATIONS
- Marketing authorisation
- 16318
- MA holder
- AMGROS I/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Hovedstaden
- Sponsor organisation
- Region Hovedstaden
- Address
- Dyrehavevej 29
- City
- Hilleroed
- Postcode
- 3400
- Country
- Denmark
Scientific contact point
- Organisation
- Nordsjaellands Hospital
- Contact name
- Kai HW Lange
Public contact point
- Organisation
- Nordsjaellands Hospital
- Contact name
- Kai HW Lange
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 1,716 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Region Midtjylland
Department of Emergency Medicine, Hospitalsparken 15, 7400, Herning
Slagelse Hospital
Department of Anaesthesiology and Intensive Care, Ingemannsvej 18, 4200, Slagelse
Holbaek Sygehus
Department of Emergency Medicine, Smedelundsgade 60, 4300, Holbæk
Hillerod Hospital
Department of Anaesthesiology and Intensive Care, Dyrehavevej 29, 3400, Hilleroed
Region Hovedstaden
Dept. of Orthopedic Surgery, Herlev Ringvej 75, 2730, Herlev
Lillebaelt Hospital
Department of Anaesthesiology, Beriderbakken 4, 7100, Vejle
Zealand University Hospital
Department of Orthopaedic Surgery, Lykkebaekvej 1., 4600, Koege
Region Midtjylland
Department of Orthopaedic, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Orthopaedic Surgery, J B Winsloews Vej 4, 5000, Odense C
Hvidovre Hospital
Department of Anaesthesiology and Intensive Care, Kettegaard Alle 30, 2650, Hvidovre
Copenhagen University Hospital
Department of Anaesthesiology and Intensive Care, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Region Midtjylland
Department of Operation and Intensive Care, Skovlyvej 15, 8930, Randers Noe
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 |
|---|---|---|---|---|---|
| Denmark | 2024-12-10 | 2024-12-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-512191-35-00_CLEAN | 6.1 |
| Protocol (for publication) | dash_danish | 1 |
| Protocol (for publication) | DASH_english | 1 |
| Protocol (for publication) | EQ-5D-5L-dansk-version-1 | 1 |
| Protocol (for publication) | EQ-5D-5L-english | 1 |
| Protocol (for publication) | PRWE_dansk | 1 |
| Protocol (for publication) | PRWE_english | 1 |
| Recruitment arrangements (for publication) | SM2_RFI_assessment part II_Recruitment and informed consenct procedure_CLEAN | 1 |
| Recruitment arrangements (for publication) | SM2_RFI_assessment part II_Recruitment and informed consenct procedure_TC | 1 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form_DANISH_CLEA | 3.3 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form_DANISH_TC | 3.3 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form_ENGLISH_CLEAN | 3.3 |
| Subject information and informed consent form (for publication) | Subject information and informed consent form_ENGLISH_TC | 3.3 |
| Summary of Product Characteristics (SmPC) (for publication) | Lidokain-adrenalin SAD injektionsvske oplsning 10 mg_ml + 5 mikrg_ml | 1 |
| Synopsis of the protocol (for publication) | The BLOCK trial synopsis | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-18 | Denmark | Acceptable 2024-09-06
|
2024-09-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-19 | Denmark | Acceptable 2025-03-31
|
2025-03-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-01 | Denmark | Acceptable 2025-06-10
|
2025-06-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-13 | Denmark | Acceptable 2025-11-03
|
2025-11-03 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-28 | Denmark | Acceptable 2025-12-08
|
2025-12-09 |