Overview
Sponsor-declared trial summary
Patients undergoing hand surgery for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint in the hand
To investigate the lateral infraclavicular plexus brachialis (LIC) block as only anesthesia for hand surgery. We will compare the duration and on-set time of the LIC block with short- and long-acting local anesthetics in combination with different concentrations but at the same volume. Both motor and sensory blockade p…
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
- 18 Apr 2024 → 23 Nov 2024
- Decision date (initial)
- 2024-03-22
- 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: Therapy
To investigate the lateral infraclavicular plexus brachialis (LIC) block as only anesthesia for hand surgery. We will compare the duration and on-set time of the LIC block with short- and long-acting local anesthetics in combination with different concentrations but at the same volume. Both motor and sensory blockade properties will also be assessed.
Conditions and MedDRA coding
Patients undergoing hand surgery for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint in the hand
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | The effect of combining lidocaine and ropivacaine on LIC-block duration and onset To investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.
Patients undergoing hand surgery for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint in the hand will be allocated into Three groups (Control group, Intervention group 1 and Intervention group 2). Ratio 1:1:1. Computer-generated random sequence allocation, fixed block size unknown to investigators.
|
Randomised Controlled | Double | [{"id":47821,"code":3,"name":"Monitor"},{"id":47822,"code":1,"name":"Subject"},{"id":47818,"code":2,"name":"Investigator"},{"id":47820,"code":4,"name":"Analyst"},{"id":47819,"code":5,"name":"Carer"}] | control: 30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine) Intervention group 1: 20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine) Intervention group 2: 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Patients undergoing hand surgery for antebrachial fractures or arthroplasty/alloplasty of a thumb base joint in the hand
Exclusion criteria 8
- BMI > 40 kg/m2
- Weight < 60 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
- Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where surgery is required
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Total time to breakthrough pain: From the completion of the LIC block to first sensation of pain from the surgical area
Secondary endpoints 4
- The onset of sensory block: From the completion of the LIC block to complete sensory blockade
- Total duration of sensory blockade: From the completion of the LIC block until the ending of sensory blockade
- Total duration of motor blockade: From the completion of the LIC block until the ending of motor blockade
- Degree of motor blockade at sensory onset (at complete sensory blockade and 45 minutes after block performance)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Lidokain-adrenalin SAD, injektionsvæske, opløsning
PRD349048 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 1000 mg milligram(s)
- 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
PRD767198 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- PERINEURAL USE
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 4 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 45010
- MA holder
- FRESENIUS KABI AB
- 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
- 800 mg milligram(s)
- Max total dose
- 4 mg/Kg milligram(s)/kilogram
- 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
- Lars Hyldborg Lundstrøm
Public contact point
- Organisation
- Nordsjaellands Hospital
- Contact name
- Lars Hyldborg Lundstrøm
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000004556
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 1 | 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 | 2024-04-18 | 2024-11-23 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-22 | Denmark | Acceptable 2024-03-19
|
2024-03-22 |