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The aim of the study is 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group: Ropi-5 | Active Comparator | 30 ml Ropivacaine 5 mg/ml (equivalent to 150 mg Ropivacaine) |
|
| Intervention group 1: Ropi-5+Lido-20 | Experimental | 20 mL Ropivacaine 5 mg/ml + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 100 mg Ropivacaine + 200 mg Lidocaine) |
|
| Intervention group 2: Ropi-7.5+Lido-20 | Experimental | 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 µg) /ml (= 150 mg Ropivacaine + 200 mg Lidocaine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.5% Injectable Solution | Drug | 30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total time to breakthrough pain | From the completion of the LIC block to first sensation of pain from the surgical area. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The onset of sensory block | From the completion of the LIC block to complete sensory blockade
This outcome is measured until the complete block is obtained, but no longer than 45 minutes. - If a complete sensory block is not obtained after 45 minutes, the LIC block is viewed as a failed block. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity at pain breakthrough | Via Numeric Rating Scale (NRS) 0 - 10 (0 = no pain; 10 = worst pain imaginable) | At pain breakthrough until a maximum of 24 hours after performed block. |
| Duration of maximum pain intensity after the blockade has ended |
Patient who have given written informed consent to participate in the study, after having understood it
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Rothe, PhD | Nordsjællands Hospital, Københavns Universitet, Hillerød | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordsjælland Hospital | Hillerød | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40859881 | Derived | Yousef S, Steensbaek MT, Bahuet AR, Knudsen RL, Harwood CD, Rosenstock CV, Andersen MF, Rothe C, Lange KHW, Norskov AK, Lundstrom LH. The effect of combining lidocaine and ropivacaine on the duration and onset time of an ultrasound-guided infraclavicular brachial plexus nerve block: A randomised controlled trial. Eur J Anaesthesiol. 2025 Dec 1;42(12):1046-1055. doi: 10.1097/EJA.0000000000002261. Epub 2025 Sep 1. |
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| Lidocaine epinephrine | Drug | 20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine) |
|
| Ropivacaine 0.75% Injectable Solution | Drug | 20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine) |
|
| Until max 45 minutes |
| Total duration of sensory blockade | From the completion of the LIC block until the ending of sensory blockade | 24 hours |
| Total duration of motor blockade | From the completion of the LIC block until the ending of motor blockade | 24 hours |
| Degree of motor blockade | Measured according to Manual Muscle Testing scale (4 point scale)
| At complete sensory blockade and otherwise 45 minutes after block performance |
Duration in hours:minutes
| After the blockade has ended until a maximum of 24 hours after performed block. |
| Occurence of adverse events (AE) and serious adverse events (SAE) | Based on phone interviews and medical records | Follow up after 24 hours and 30 days |
| Failed blockade | A block is viewed upon as failed if complete sensory block has not been achieved within 45 minutes or if supplemental local anaesthetic is needed before or during surgery. | Evaluated 30 minutes after completed surgery |
| The patient's experience of the treatment (patient satisfaction) | Via Numeric Rating Scale (NRS) 0 - 10 (0 = very dissatisfied; 10 = very satisfied) | 24 hours |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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