Determination of an anesthetic concentration that can be used in the future as a so-called active placebo.
Zusammenfassung der Studie
Local nerve anesthesia with local anesthetics is used in pain medicine for various purposes: diagnostic blocks for pain relief, prognostic blocks to assess the effectiveness of future treatments, and therapeutic blocks for long-term pain relief. However, there is limited scientific evidence for their effectiveness and safety, as comprehensive placebo-controlled studies are lacking. A barrier to researching nerve blocks in such studies is the difficulty in ensuring successful blinding of participants and examiners, as nerve blocks often cause numbness and motor impairments. This study aims to determine the correct dosage of a placebo anesthetic to enable future studies that can more accurately examine the effects of nerve blocks. * Placebo-controlled means that in a study, in addition to the actual anesthetic, a sham anesthetic (placebo) is also used.
(BASEC)
Untersuchte Intervention
The concentration of the anesthetic (Ropivacaine) is determined using an up-down model. The initial concentration is 0.1% of the anesthetic, which is very likely to lead to a nerve block after 60 minutes. Depending on how the first subject reacts, the next subject will receive a higher or lower dose. The dose is increased (+0.025%) if: - the pain relief is less than 50%, OR - the pain relief is between 50% and 75% and there is no sensory or strength impairment. The dose is reduced (-0.025%) if: - the pain relief is between 50% and 75% and there is a sensory or strength impairment, OR - the pain relief is more than 75%. This method helps to reduce the number of people needed to find out how much Ropivacaine is needed to achieve pain relief without the affected individuals experiencing noticeable sensory or strength impairment. For safety reasons, the highest concentration of Ropivacaine to be used is limited to 0.5%. This corresponds to the concentration used in daily practice for nerve blocks in regional anesthesia to achieve complete anesthesia during surgical procedures.
(BASEC)
Untersuchte Krankheit(en)
Investigation of the dose-dependent effects of Ropivacaine, an anesthetic.
(BASEC)
- Individuals in good health - Age: from ≥ 18 years to < 65 years - Written consent after information (BASEC)
Ausschlusskriterien
- Known intolerance/hypersensitivity to the anesthetic being studied (Ropivacaine) - Chronic or acute pain - Use of pain-relieving medications (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Universitätsklinik Balgrist
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof Dr. med Urs Eichenberger
+41 44 386 38 32
anaesthesiologie@clutterbalgrist.chAnästhesie Universitätsklinik Balgrist
(BASEC)
Allgemeine Auskünfte
Deputy Head of Anesthesiology,
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Allgemeine Auskünfte
Deputy Head of Anesthesiology
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Allgemeine Auskünfte
Deputy Head of Anesthesiology
(ICTRP)
Wissenschaftliche Auskünfte
Deputy Head of Anesthesiology,
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
18.10.2024
(BASEC)
ICTRP Studien-ID
NCT06668116 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The impact of local anesthetic dilution on the possibility of blinding studies involving peripheral nerve blocks. A randomized, prospective, monocentric study on volunteers (BASEC)
Wissenschaftlicher Titel
The Impact of Local Anesthetic Dilution on the Possibility of Blinding Studies Involving Peripheral Nerve Blocks. A Randomized, Prospective, Monocentric Study on Volunteers (ICTRP)
Öffentlicher Titel
The Impact of Local Anesthetic Dilution on Possible Blinding for Nerve Blocks (ICTRP)
Untersuchte Krankheit(en)
Healthy (ICTRP)
Untersuchte Intervention
Drug: Ropivacaine 0,1%Other: NaCl (placebo) (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Heat pain sensitivity;Self-report of sensory block;Self-report of motor block (ICTRP)
Evaluation of the C-fiber block;Evaluation of the A-delta fiber block;Evaluation of the A-beta fiber block;Evaluation of the A-alpha fiber block (motor block);Offset analgesia (ICTRP)
Registrierungsdatum
30.10.2024 (ICTRP)
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Hagen Bomberg, Medical Doctor;Hagen Bomberg, Medical Doctor, hagen.bomberg@balgrist.ch, 0041 44 386 38 32, Deputy Head of Anesthesiology, (ICTRP)
Sekundäre IDs
2024-01431 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06668116 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar