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| Name | Class |
|---|---|
| Innovation Fund Denmark | INDIV |
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An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.
An interventional randomized controlled crossover trial, with the purpose to elucidate the reproducibility in nerve block duration on 20 healthy volunteers in Denmark.
There will be two trial arms:
1: Day one; Right side low dose nerve block and left side high dose nerve block. Repeated after 24 hours. Day three; Left side low dose nerve block and right side high dose nerve block. Repeated after 24 hours
2: Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours
All volunteers will receive two peripheral nerve blocking catheters adjacent to the common peroneal nerve and will be treated two times on each side with Lidocaine 0.5% 5 mL and 10 mL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right-low, left-high | Experimental | The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 5 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 10 mL. This will be repeated after 24 hours. |
|
| Right-high, left-low | Experimental | The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 10 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 5 mL. This will be repeated after 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion, Lidocaine, 0.5%, 5 mL | Drug | A catheter-based perineural infusion of 5 mL Lidocaine 0.5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of insensitivity towards cold | Time from nerve block onset time (T1) to nerve block remission (T2) | Up to 10 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Onset time | Time from infusion (T0) to onset (T1) of the nerve blocking effect | Up to 30 minutes |
| Degree of sensory nerve block | A four step grading-scale of sensory nerve block intensity. 1 = normal, 2 = different, 3 = warm, 4 = no feeling. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kai L Lange, MD, DMSci | Nordsjaellands Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed | Hillerød | Capital Region of Denmark | 3400 | Denmark |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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We will use a two-armed crossover design.
Day one; Right side low dose nerve block and left side high dose nerve block
Day one; Left side low dose nerve block and right side high dose nerve block
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The process of intervention-implementation and intervention will not be in the participant's line of sight.
Investigators will not be in the room during the intervention. Outcome assessors will not be in the room during the intervention.
| Infusion, Lidocaine, 0.5%, 10 mL | Drug | A catheter-based perineural infusion of 10 mL Lidocaine 0.5% |
|
|
| Up to 10 hours |
| Degree of motor nerve block | A three step grading-scale of motor nerve block intensity. 1 = normal, 2 = decreased strength, 3 = no strength. | Up to 10 hours |
| Aniline Compounds |
| D000588 | Amines |
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |