Distal Radius FracturesPhase 3NCT06379490
Ultrasound-guided Infraclavicular Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures
A Phase 3 study testing Ropivacaine 0.2% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.5% Injectable Solution in people with Distal Radius Fractures and Lidocaine, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators will compare the pain-relieving and muscle-relaxing properties of the LIC block with short- and long-acting local anesthetics in different concentrations… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fractures, Lidocaine, Ropivacaine
- What is being tested?
- Ropivacaine 0.2% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.5% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Apr 2024to 18 Jun 2025
- Phase
- Phase 3
- 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
- Patients who have given written informed consent to participate in the study after having understood it, as well as:
- Having a distal radius fracture requiring closed reduction
Who cannot join
- Patients who meet one or more of the following criteria will be excluded from participating in the study:
- BMI > 40 kg/m2
- Weight < 50 kg
- Age < 18 years
- American Society of Anesthesiologists (ASA) physical status classification system grade >3
- Allergy to experimental drugs
Show all 9Show fewer
- 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 closed reduction is required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators 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
- Distal Radius Fractures, Lidocaine, Ropivacaine, Fracture Dislocation, Closed Reduction of Fracture and Application of Plaster Cast, Colles' Fracture
- Being tested
- Ropivacaine 0.2% Injectable Solution, Lidocaine epinephrine, Ropivacaine 0.5% Injectable Solution
- Keywords
- anesthetics, local, regional anesthesia, peripheral nerve block, brachial plexus block, lateral infraclavicular block, closed reduction, distal radius fracture, colles' fracture, wrist fracture
- Medical subject headings
- Wrist Fractures, Fracture Dislocation, Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2% Injectable SolutionDrug
Also called Ropivacaine 2 mg/ml
30 ml of Ropivacaine 0.2% = 60 mg ropivacaine
Lidocaine epinephrineDrug
Also called Lidocaine 10 mg/ml
30 ml of Lidocaine 1% with 5 μg/ml epinephrine = 300 mg lidocaine + 150 μg epinephrine
Ropivacaine 0.5% Injectable SolutionDrug
Also called Ropivacaine 5 mg/ml
30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine 5 mg/ml | Active comparator | 30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once) Receives: Drug: Ropivacaine 0.5% Injectable Solution |
| Ropivacaine 2 mg/ml | Experimental | 30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once) Receives: Drug: Ropivacaine 0.2% Injectable Solution |
| Lidocaine 10 mg/ml | Experimental | 30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once) Receives: Drug: Lidocaine epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block success
The incidence of successful blockade 45 minutes after block performance.
The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves.
Sensory blockade assessment:
- A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation.
- A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation).
Motor blockade assessment:
- Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis.
- A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points.
Successful blockade:
- Complete sensory and motor blockade 45 minutes after block performance.
Measured: 45 minutes after block performance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start23 Apr 2024
- Primary completion18 Jun 2025
- Study completion18 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Distal Radius FracturesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders K. Nørskov, PhD, Principal investigator, Copenhagen University Hospital - North Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379490
- Sponsor's protocol ID
- CTA no: 2024-510572-20-00
- Other IDs
- 2024-510572-20-00, P-2023-296
- Status last verified
- May 2025
- First submitted
- 18 Apr 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Steensbaek MT, Yousef S, Bahuet AR, Knudsen RL, Bjulf RHF, Pisljagic S, Thomsen JH, Piosik Z, Kaaber PB, Rothe C, Harwood CD, Jellestad AL, Lange KHW, Lundstrom LH, Norskov AK. Effect of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures: A Randomized Controlled Noninferiority Trial. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70246. doi: 10.1111/aas.70246.
PubMed 42104772
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures - A Randomized Controlled Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT06379490
- Acronym / sponsor ID
- CTA no: 2024-510572-20-00
- Conditions
- Distal Radius Fractures, Lidocaine, Ropivacaine, Fracture Dislocation, Closed Reduction of Fracture and Application of Plaster Cast, Colles' Fracture
- Keywords
- anesthetics, local, regional anesthesia, peripheral nerve block, brachial plexus block, lateral infraclavicular block, closed reduction, distal radius fracture, colles' fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Study start
- 23 Apr 2024 (actual)
- Primary completion
- 18 Jun 2025 (actual)
- Study completion
- 18 Jun 2025 (actual)
- First posted
- 23 Apr 2024 (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.
To investigate the feasibility of the lateral infraclavicular plexus brachialis (LIC) block for acute closed reduction of distal radius fractures, the investigators 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine 5 mg/ml | Active comparator | Drug: Ropivacaine 0.5% Injectable Solution30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once) |
| Ropivacaine 2 mg/ml | Experimental | Drug: Ropivacaine 0.2% Injectable Solution30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once) |
| Lidocaine 10 mg/ml | Experimental | Drug: Lidocaine epinephrine30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have given written informed consent to participate in the study after having understood it, as well as:
- Having a distal radius fracture requiring closed reduction
Key exclusion criteria (9 listed)
- Patients who meet one or more of the following criteria will be excluded from participating in the study:
- BMI > 40 kg/m2
- Weight < 50 kg
- Age < 18 years
- American Society of Anesthesiologists (ASA) physical status classification system grade >3
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 |
|---|---|---|
| Ropivacaine 0.2% Injectable SolutionAlso: Ropivacaine 2 mg/ml30 ml of Ropivacaine 0.2% = 60 mg ropivacaine | Drug | Ropivacaine 2 mg/ml |
| Lidocaine epinephrineAlso: Lidocaine 10 mg/ml30 ml of Lidocaine 1% with 5 μg/ml epinephrine = 300 mg lidocaine + 150 μg epinephrine | Drug | Lidocaine 10 mg/ml |
| Ropivacaine 0.5% Injectable SolutionAlso: Ropivacaine 5 mg/ml30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine | Drug | Ropivacaine 5 mg/ml |
Primary outcome
Block success
Time frame: 45 minutes after block performance
The incidence of successful blockade 45 minutes after block performance. The following 4 nerves will be tested: radial, musculocutaneous, ulnar and median nerves. Sensory blockade assessment: * A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation. * A complete sensory blockade is defined as all four nerves obtaining 3 points (no cold sensation). Motor blockade assessment: * Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, the movement against resistance is possible, 2 points = a slight difference, the movement against slight resistance is possible, 1 point = movement is significantly compromised, 0 points = paralysis. * A complete motor blockade is defined as all four nerves obtaining: 1 point or 0 points. Successful blockade: • Complete sensory and motor blockade 45 minutes after block performance.
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 26 Jun 2025.
- Derived from this study: PubMed 42104772Steensbaek MT, Yousef S, Bahuet AR, Knudsen RL, Bjulf RHF, Pisljagic S, Thomsen JH, Piosik Z, Kaaber PB, Rothe C, Harwood CD, Jellestad AL, Lange KHW, Lundstrom LH, Norskov AK. Effect of Ultrasound-Guided Lateral Infraclavicular Brachial Plexus Block With Lidocaine or Ropivacaine for Closed Reduction of Distal Radius Fractures: A Randomized Controlled Noninferiority Trial. Acta Anaesthesiol Scand. 2026 Jul;70(6):e70246. doi: 10.1111/aas.70246.
- Individual participant dataSharing planned: No
Related trials for Distal Radius Fractures
Recruiting
No Reduction Compared to Closed Reduction for Distal Radius Fractures in Patients Over 65 or Older
Distal Radius Fracture, Casting
Active, not recruiting
Immediate Mobilization Versus 2 Weeks Cast Immobilization After Distal Radius Fracture Treated With Volar Locking Plate
Distal Radius Fracture
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Not yet recruiting
One Inch Punch High Impact Training Randomized Control Trial (1'' Punch HIT RCT)
Distal Radius Fracture
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
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.
Anders K. Nørskov, PhD principal investigator
Copenhagen University Hospital - North Zealand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine 0.2% Injectable Solution, Lidocaine epinephrine and Ropivacaine 0.5% Injectable Solution in people with Distal Radius Fractures and Lidocaine, run by Nordsjaellands Hospital at 1 site in Denmark.
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 2 inclusion and 9 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 26 Jun 2025. 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 Denmark. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Block success (time frame: 45 minutes after block performance). 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 NCT06379490, which also lists 1 linked publication.
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 26 Jun 2025.