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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-510572-20-00 | EU Trial (CTIS) Number | ||
| P-2023-296 | Other Identifier | Privacy - Region Hovedstaden |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine 5 mg/ml | Active Comparator | 30 ml of ropivacaine 5 mg/ml (Injectable solution - perineural administration - only once) |
|
| Ropivacaine 2 mg/ml | Experimental | 30 ml of ropivacaine 2 mg/ml (Injectable solution - perineural administration - only once) |
|
| Lidocaine 10 mg/ml | Experimental | 30 ml of lidocaine 10 mg/ml with epinephrine 5 μg/ml (Injectable solution - perineural administration - only once) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.2% Injectable Solution | Drug | 30 ml of Ropivacaine 0.2% = 60 mg ropivacaine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Motor blockade assessment:
Successful blockade: • Complete sensory and motor blockade 45 minutes after block performance. | 45 minutes after block performance |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of sensory and motor blockade | Degree of sensory and motor blockade 30 and 45 minutes after block performance. Sensory blockade assessment:
Motor blockade assessment:
|
Inclusion Criteria:
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
Exclusion Criteria:
Patients who meet one or more of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Anders K. Nørskov, PhD | Copenhagen University Hospital - North Zealand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital - North Zealand | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42104772 | Derived | 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. |
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| Lidocaine epinephrine | Drug | 30 ml of Lidocaine 1% with 5 μg/ml epinephrine = 300 mg lidocaine + 150 μg epinephrine |
|
|
| Ropivacaine 0.5% Injectable Solution | Drug | 30 mL of Ropivacaine 0.5% = 150 mg Ropivacaine |
|
|
| 30 to 45 minutes after block performance |
| Total duration of sensory blockade | From the completion of the LIC block until the ending of the sensory blockade. Duration in hours:minutes. | 24 hours after completed block performance |
| Total duration of motor blockade | From the completion of the LIC block until the ending of motor blockade. Duration in hours:minutes. | 24 hours after completed block performance |
| Pain intensity before block performance | Pain intensity measured before block performance with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)) | Up to 45 minutes after inclusion interview |
| Time to pain relief/lowest pain intensity | Time to pain relief/lowest pain intensity after block performance and before performing the closed reduction Duration in hours:minutes | Up to 45 minutes after block performance |
| Pain intensity during closed reduction | Pain intensity measured during closed reduction with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)) | Duration of closed reduction (approx. 5 to 10 minutes) |
| Pain intensity during cast application | Pain intensity measured during cast application with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)) | Duration of cast application (approx. 5 to 10 minutes) |
| Time to pain breakthrough after the blockade has ended | Time after block performance until pain breakthrough defined as NRS>3 (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)) Duration in hours:minutes | Up to 24 hours after block performance |
| Maximum pain intensity after the blockade has ended | Pain intensity measured after the blockade has ended with a numeric rating scale (NRS 0 - 10 (0 = no pain; 10 = worst pain imaginable)) | Up to 24 hours after block performance |
| Duration of maximum pain intensity after the blockade has ended | Time period of maximum pain intensity after the blockade has ended Duration in hours:minutes | Up to 24 hours after block performance |
| Amount of strong painkillers consumed by patients within 24 hours after closed reduction | Amount of strong painkillers consumed by patients within 24 hours after closed reduction will be measured in 24-hour morphine equivalents (milligrams). | 24 hours after completed block performance |
| Grading of closed reduction difficulty | Grading of closed reduction difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult)) | Duration of closed reduction (approx. 5 to 10 minutes) |
| Quality of closed reduction evaluated by X-ray imaging | Quality of closed reduction evaluated by X-ray imaging using the following radiological criteria:
| 24 hours and 30 days after block performance |
| Attempts used for closed reduction | Number of attempts used for closed reduction. One attempt is defined as closed reduction before X-ray control imaging. | Up to 4 hours after block application |
| Grading of casting difficulty | Grading of casting difficulty measured with a numeric rating scale (NRS 0 - 10 (0 = no difficulty; 10 = very difficult)) | Duration of cast application (approx. 5 to 10 minutes |
| The patient's experience of the treatment | The patient's experience of the treatment using a numeric rating scale (NRS 0 - 10 (0 = very dissatisfied; 10 = very satisfied)) | Up to 24 hours after block performance |
| Occurence of adverse events (AE) and serious adverse events (SAE) | Adverse events are defined as any harmful or unwanted events, signs, or symptoms that occur during participation in the study period. Serious adverse events are defined as events resulting in death, a life-threatening condition, permanent disability, hospital admission, or prolonged hospital admission. Based on phone interviews and medical records 24 hours and 30 days after the procedure. | 24 hours and 30 days after block performance |
| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| D000072039 | Fracture Dislocation |
| D003100 | Colles' Fracture |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D011885 | Radius Fractures |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
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