Investigating a placebo for nerve blocks to improve clinical trials
The Impact of Local Anesthetic Dilution on the Possibility of Blinding Studies Involving Peripheral Nerve Blocks. A Randomized, Prospective, Monocentric Study on Volunteers
This study is testing a new fake anesthetic that feels like a real nerve block to help improve future research on pain management treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Balgrist University Hospital Academic / other |
| Locations | 2 sites (Zurich, ZH and 1 other locations) |
| Trial ID | NCT06668116 on ClinicalTrials.gov |
What this trial studies
This study aims to identify an effective placebo anesthetic that mimics the sensations of a real nerve block without providing actual pain relief. By developing a convincing placebo, the researchers hope to enhance the validity of future placebo-controlled studies on nerve blocks, which are essential for understanding their efficacy in pain management. The study will involve healthy participants aged 18 to 65, who will receive either the active anesthetic or the placebo. The ultimate goal is to establish a methodology that allows for rigorous investigations into the effectiveness of nerve blocks.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 65 with no history of chronic or acute pain.
Not a fit: Patients with known allergies to local anesthetics, chronic pain conditions, or those taking pain-modulating medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more reliable evidence regarding the efficacy of nerve blocks, ultimately improving pain management strategies for patients.
How similar studies have performed: While the approach of developing a convincing placebo for nerve blocks is novel, similar methodologies have shown promise in other areas of clinical research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA I - II, both sexes * ≥ 18 years old * \< 65 years old * Written informed consent as documented by signature Exclusion Criteria: * Known allergy or hypersensitivity to a ropivacaine, amide local anesthetics or ultrasound gel * Any history of chronic or acute pain at the moment of enrollment into the study * Treatment with any substance having a relation to pain or pain modulation (antidepressants, opioids, benzodiazepines, anticonvulsants) * Intake of any analgesic 48 hours prior to the conduction of any of the study stages * Severe coagulopathy * History of cardiovascular disease * History of alcohol abuse or the intake of psychotropic drugs * Pregnancy, ruled out by history * Infection at the injection site or a systemic infection * Fever of unknown origin * Motor or sensory abnormalities in the arm * Previous enrollment into the current study
Where this trial is running
Zurich, ZH and 1 other locations
- Balgrist University Hospital — Zurich, Zh, Switzerland (Not_yet_recruiting)
- Balgrist University Hospital — Zurich, Zh, Switzerland (Recruiting)
Study contacts
- Principal investigator: Hagen Bomberg, Medical Doctor — Deputy Head of Anesthesiology
- Study coordinator: Hagen Bomberg, Medical Doctor
- Email: hagen.bomberg@balgrist.ch
- Phone: 0041 44 386 38 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.