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| Name | Class |
|---|---|
| Innovation Fund Denmark | INDIV |
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Background: Local anesthetic (LA) concentration and nerve block duration is sparsely described in a heterogenic study mass.
Aim: To investigate the effect of LA concentration on peripheral nerve block duration in healthy volunteers.
Methods: Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose.
Primary endpoint: Sensory nerve block defined by insensitivity towards cold.
Background:
Important factors for a safe and successful nerve block include volume, dose and concentration of local anesthetic (LA). Knowing the duration of peripheral nerve blocks is important to prevent pain breakthrough. With the advancements in ultrasound (US)-guided nerve block techniques it has been possible to substantially reduce the amount of LA required to perform a successful nerve block. This has reduced the risk of systemic toxicity. However, lowering LA volume may reduce nerve block duration, but the extent of this is sparsely described in a heterogenic study mass.
Diluted and large volumes of LA seem to correlate with nerve block duration. Furthermore, increasing LA concentration seems to increase the level of motor block, but not the block duration. A long-lasting nerve block without dense motor block is preferable for optimized pain control and better opportunities to rehabilitate/ambulate.
Aim:
To investigate the effect of LA concentration on common peroneal nerve block duration in healthy volunteers.
Methods:
Randomization of 60 healthy volunteers who will receive 1 of 5 different volumes of LA (ropivacaine) using a constant dose (10mg).
Primary outcome: Duration of sensory nerve block defined by insensitivity towards cold.
Secondary outcome: Duration of motor nerve block defined by either paresis or paralysis.
Explorative outcomes: Degrees of sensory and motor nerve block; Onset times of sensory and motor nerve block; Length of neural exposure to LA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volume: 2.5 mL | Experimental | Perineural injection of ropivacaine 10 mg, 2.5 mL. Concentration: Ropivacaine 4 mg/mL. |
|
| Volume: 5 mL | Experimental | Perineural injection of ropivacaine 10 mg, 5 mL. Concentration: Ropivacaine 2 mg/mL |
|
| Volume: 10 mL | Experimental | Perineural injection of ropivacaine 10 mg, 10 mL Concentration: Ropivacaine 1 mg/mL |
|
| Volume: 15 mL | Experimental | Perineural injection of ropivacaine 10 mg, 15mL Concentration: Ropivacaine 0.67 mg/mL |
|
| Volume: 20 mL | Experimental | Perineural injection of ropivacaine 10 mg, 20mL Concentration: Ropivacaine 0.5 mg/mL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of sensory nerve block | Insensitivity towards cold. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation. | 1-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of motor nerve block | Paresis or paralysis of ankle dorsiflexion. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation. | 1-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Length of neural exposure to local anesthetic | Ultrasound-guided measurement of the perineural spread of local anesthetic. From the most distal to the most proximal point. Measured in millimetres. | 10 minutes |
| Onset of sensory nerve block |
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Claus B Christiansen, MD | Nordsjaellands Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nordsjællands Hospital | Hillerød | Danmark | 3400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31789898 | Derived | Christiansen CB, Madsen MH, Molleskov E, Rothe C, Lundstrom LH, Lange KHW. The effect of ropivacaine concentration on common peroneal nerve block duration using a fixed dose: A randomised, double-blind trial in healthy volunteers. Eur J Anaesthesiol. 2020 Apr;37(4):316-322. doi: 10.1097/EJA.0000000000001112. |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
Insensitivity towards cold. Testing will start 10 minutes after end of LA infusion and continue every 5 minutes until onset is apparent.
| 10-180 minutes |
| Onset of motor nerve block | Paresis or paralysis of ankle dorsiflexion. Testing will start 10 minutes after end of LA infusion and continue every 5 minutes until onset of sensory nerve block is apparent. | 10-180 minutes |
| Degree of sensory nerve block | Grading system using a 4-level scale and compared to the contralateral leg: 1) normal; 2) different; 3) warmth; 4) no sensation. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation. | 1-24 hours |
| Degree of motor nerve block | Grading system using a 3-level scale and compared to the contralateral leg: 1) normal; 2) paresis; 3) paralysis. Testing will start after onset of sensory nerve block and will be done in intervals of 60 minutes hereafter and continue until return of normal sensation. | 1-24 hours |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |