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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001752-31 | EudraCT Number |
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To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.
The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACB with lidocaine 5 mg/ml | Experimental | Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus |
|
| ACB with lidocaine 15 mg/ml | Experimental | Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adductor canal block with 20 ml lidocaine, single bolus | Drug | Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sensory block assessed with pinprick. | Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sensory block assessed by heat pain detection threshold | Duration is defined as time from block performance until recovery of normal sensation (+/- 2 degrees Celsius from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Duration of sensory block assessed by warmth detection threshold |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pia Jæger, MD | Rigshospitalet, Denmark | Principal Investigator |
| Jørgen B Dahl, Professor | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27537926 | Derived | Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Grevstad U, Siersma V, Fabritius ML, Dahl JB. Effect of Total Dose of Lidocaine on Duration of Adductor Canal Block, Assessed by Different Test Methods: A Report of Two Blinded, Randomized, Crossover Studies in Healthy Volunteers. Anesth Analg. 2016 Oct;123(4):1026-32. doi: 10.1213/ANE.0000000000001517. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Duration is defined as time from block performance until recovery of normal sensation (return to baseline value + 2 degrees Celsius or less from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. |
| 0-10 hours |
| Duration of sensory block assessed by pain during 1 minute of warmth stimulation | Duration is defined as time from block performance until recovery of normal sensation (return to baseline VAS pain scores +/-10 mm from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation | Duration is defined as time from block performance until recovery of normal sensation (return to baseline preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Duration of sensory block assessed by cold sensation with an alcohol swab | Duration is defined as time from block performance until recovery of normal sensation assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Duration of motor block assessed as maximum voluntary isometric contraction. | Duration is defined as time from block performance until recovery of normal muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours |
| Time to onset of sensory block assessed by pinprick. | Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-2 hours |
| Aniline Compounds |
| D000588 | Amines |