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The Impact of Local Anesthetic Dilution on Possible Blinding for Nerve Blocks

NCT06668116 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2025-11-28

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Ropivacaine 0,1%

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.

OTHER

NaCl (placebo)

0.9 % NaCl solution (saline) injection

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Hagen Bomberg, Medical Doctor · Deputy Head of Anesthesiology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668116 on ClinicalTrials.gov