Determination of an anesthetic concentration that can be used in the future as a so-called active placebo.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
- Known intolerance/hypersensitivity to the anesthetic being studied (Ropivacaine) - Chronic or acute pain - Use of pain-relieving medications (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Universitätsklinik Balgrist
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof Dr. med Urs Eichenberger
+41 44 386 38 32
anaesthesiologie@clutterbalgrist.chAnästhesie Universitätsklinik Balgrist
(BASEC)
Informazioni generali
Deputy Head of Anesthesiology,
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Informazioni generali
Deputy Head of Anesthesiology
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Informazioni generali
Deputy Head of Anesthesiology
(ICTRP)
Informazioni scientifiche
Deputy Head of Anesthesiology,
0041 44 386 38 32
hagen.bomberg@balgrist.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
18.10.2024
(BASEC)
ID di studio ICTRP
NCT06668116 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
The impact of local anesthetic dilution on the possibility of blinding studies involving peripheral nerve blocks. A randomized, prospective, monocentric study on volunteers (BASEC)
Titolo accademico
The Impact of Local Anesthetic Dilution on the Possibility of Blinding Studies Involving Peripheral Nerve Blocks. A Randomized, Prospective, Monocentric Study on Volunteers (ICTRP)
Titolo pubblico
The Impact of Local Anesthetic Dilution on Possible Blinding for Nerve Blocks (ICTRP)
Malattie studiate
Healthy (ICTRP)
Intervento studiato
Drug: Ropivacaine 0,1%Other: NaCl (placebo) (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
30.10.2024 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Hagen Bomberg, Medical Doctor;Hagen Bomberg, Medical Doctor, hagen.bomberg@balgrist.ch, 0041 44 386 38 32, Deputy Head of Anesthesiology, (ICTRP)
ID secondari
2024-01431 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06668116 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile