At a glance
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The Impact of Local Anesthetic Dilution on the Possibility of Blinding Studies Involving Peripheral Nerve Blocks. A Randomized, Prospective, Monocentric Study on Volunteers
In Brief
A clinical study evaluating Ropivacaine 0,1% and NaCl (placebo) for Healthy. Completed, enrolled 17 participants across 1 site.
Detailed Summary
This study aims to determine the appropriate dosage of a placebo anesthetic to enable future placebo-controlled studies that can more accurately examine the effects of nerve blocks. The main challenge in conducting such studies is the difficulty in blinding participants and researchers due to the noticeable effects of nerve blocks, such as numbness and motor impairments. The goal is to find a placebo solution that can: * Mimic the sensations of a real nerve block * Not provide actual pain relief * Allow for effective blinding in future studies By developing an appropriate placebo, researchers hope to: * Enable more rigorous investigations into the efficacy of nerve blocks for pain management * Conduct comprehensive placebo-controlled studies, which are currently lacking in the field * Overcome the obstacle of ensuring successful blinding in nerve block research This study is focused to establish a methodology for creating a convincing placebo that can be used in future research to more accurately assess the true effects of nerve blocks in pain medicine.
Study Details
Timeline
Interventions
The study uses ropivacaine for nerve blocks, starting at 0.1% concentration and capped at 0.5% for safety. Concentration adjustments are made based on each participant's response 60 minutes post-injection: * Increase by 0.025% if pain reduction is \<50% * Increase by 0.025% if reduction is 50-75% without sensory/motor block * Decrease by 0.025% if reduction is 50-75% with sensory/motor block * Decrease by 0.025% if reduction is \>75%. Pain is assessed using a Numerical Rating Scale. The study employs Dixon's up-and-down method for five cycles to determine the optimal concentration for effective pain relief without significant numbness or weakness.
0.9 % NaCl solution (saline) injection