Overview
Sponsor-declared trial summary
Distal radius fractures with need of acute closed reduction
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, we will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same …
Key facts
- Sponsor
- Nordsjaellands Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 23 Apr 2024 → 18 Jun 2025
- Decision date (initial)
- 2024-04-04
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Dept. of Anaesthesiology and Intensive Care Nordsjællands Hospital, Hillerød, Denmark
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, we will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations but at the same volume. In addition to motor and sensory blockade during repositioning, feasibility will also be assessed by other patient-related and block-related factors, as well as by factors related to the repositioning and plastering procedure.
Conditions and MedDRA coding
Distal radius fractures with need of acute closed reduction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients having a distal radius fracture requiring closed reduction
Exclusion criteria 8
- BMI > 40 kg/m2
- Weight < 50 kg
- Age < 18 years
- ASA physical status classification system grade >3
- Allergy to experimental drugs
- Patients who cannot cooperate with the examinations or treatment
- Patients who do not understand or speak Danish or English
- Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where closed reduction is required
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The incidence of successful blockade 45 minutes after block performance
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD767196 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 45007
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lidokain-adrenalin SAD, injektionsvæske, opløsning
PRD349048 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- 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
Comparator 1
PRD767197 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 150 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 45009
- MA holder
- FRESENIUS KABI AB
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Nordsjaellands Hospital
- Sponsor organisation
- Nordsjaellands Hospital
- 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 · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 63 | 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 |
|---|---|---|---|---|---|
| Denmark | 2024-04-23 | 2025-06-18 | 2024-05-03 | 2025-05-19 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-03 | Denmark | Acceptable 2024-04-04
|
2024-04-04 |