A Phase 4 interventional study of Ropivacaine in Peripheral Nerve Block, sponsored by Nordsjaellands Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-08.
Sponsored by Nordsjaellands Hospital · Phase 4, Interventional, and Basic science
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.
Nordsjaellands Hospital is the lead sponsor of 89 studies on the registry; 21 are open to participants now.
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Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Perineural injection of ropivacaine 10 mg, 2.5 mL. Concentration: Ropivacaine 4 mg/mL.
Drug: Ropivacaine
Perineural injection of ropivacaine 10 mg, 5 mL. Concentration: Ropivacaine 2 mg/mL
Drug: Ropivacaine
Perineural injection of ropivacaine 10 mg, 10 mL Concentration: Ropivacaine 1 mg/mL
Drug: Ropivacaine
Perineural injection of ropivacaine 10 mg, 15mL Concentration: Ropivacaine 0.67 mg/mL
Drug: Ropivacaine
Perineural injection of ropivacaine 10 mg, 20mL Concentration: Ropivacaine 0.5 mg/mL
Drug: Ropivacaine
Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)
Also known as: Isotonic saline (natriumchloride)
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.
Time frame: 1-24 hours
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.
Time frame: 1-24 hours
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.
Time frame: 10 minutes
Onset of sensory nerve block
Insensitivity towards cold. Testing will start 10 minutes after end of LA infusion and continue every 5 minutes until onset is apparent.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1-24 hours
Plan to share: Undecided
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Studies of the drug tested here: Ropivacaine
Nordsjaellands Hospital