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Ropivacaine

Questo articolo riassume studi clinici che valutano Ropivacaine in diversi contesti chirurgici e di terapia intensiva. I trial mirano soprattutto a misurare il controllo del dolore, il bisogno di oppioidi e il recupero funzionale in pazienti sottoposti a procedure specifiche.

Table of contents

Overview of the clinical trials

These studies investigate Ropivacaine in different clinical settings where pain control is important.[1][2][3][4][5]

Most of the trials are Phase 3 studies, which usually compare treatments in larger groups of patients.[1][2][3][5] One study is listed as Low Intervention, meaning it uses a low-risk research approach rather than a standard drug development phase label.[4]

The studies are interventional, which means researchers assign a treatment or procedure and then measure the results.[1][2][3][4][5]

Settings and patient populations

The trials include people in intensive care during pleural drainage, patients having throat and neck cancer surgery, patients having cardiac sternotomy surgery, people with hemorrhoidal disease undergoing radiofrequency treatment, and patients having hallux valgus repair surgery.[1][2][3][4][5]

These are not general studies for all patients; each trial focuses on a specific procedure or condition.[1][2][3][4][5]

In the cancer surgery study, the goal is to reduce the amount of IV morphine used in the first 24 hours after surgery.[2] In the hallux valgus study, the focus is on ankle blocks and how long the sensory block lasts.[5]

Study design and main endpoints

The main endpoint is the main result the researchers want to measure.[1][2][3][4][5]

In the pleural drainage study, the main endpoint is the intensity of acute pain during drainage, measured with a numerical scale.[1]

In the throat and neck cancer surgery study, the main endpoint is the amount of morphine used after the operation, including morphine given in the recovery room and through PCA.[2]

In the cardiac sternotomy study, the main endpoint is the change in forced vital capacity (FVC), which is a measure of how much air a person can blow out after surgery.[3]

In the hemorrhoid procedure study, the main endpoint is the pain score on the visual analogue scale (VAS) six hours after the procedure starts.[4]

In the hallux valgus study, the main endpoint is the difference in the duration of the sensory blocks over a 48-hour period.[5]

Trial-by-trial summary

NCT03984656 studies a serratus plane block during pleural drainage in intensive care, comparing it with local anesthesia to see how well it controls acute pain.[1] The trial is Phase 3, is authorised, and plans to include 70 participants.[1]

2024-510942-15-00 studies a superficial cervical plexus block in oncological throat and neck surgery, with the goal of lowering postoperative morphine use in the first 24 hours.[2] This trial is Phase 3, authorised, and has an enrollment of 346 participants.[2]

2024-513301-30-00 studies a parasternal analgesic block after cardiac sternotomy surgery to assess postoperative breathing function.[3] It is a Phase 3 study, completed, with 84 participants.[3]

NCT05519189 studies perianal infiltration during radiofrequency treatment of hemorrhoidal disease and compares pain at six hours after the procedure.[4] It is completed, has a Low Intervention design, and includes 134 participants.[4]

NCT06185608 studies different concentrations of Ropivacaine for ultrasound-guided ankle blocks in hallux valgus repair surgery, with a focus on how long the sensory block lasts.[5] It is a Phase 3 study, authorised, and plans to enroll 174 participants.[5]

What patients should know about these studies

These trials are designed to answer practical questions about pain relief, recovery, and the effect of locoregional anesthesia in specific procedures.[1][2][3][4][5]

Some studies compare Ropivacaine with another approach, while others look at different concentrations or techniques used with Ropivacaine.[1][4][5]

The results are measured with patient-relevant outcomes such as pain scores, opioid use, and breathing function after surgery.[1][2][3][4][5]

Trial ID Phase Condition studied Status Enrollment
NCT03984656 Phase 3 Anesthesia / intensive care; pleural drainage Authorised 70
2024-510942-15-00 Phase 3 Cancer surgery; throat and neck surgery Authorised 346
2024-513301-30-00 Phase 3 Cardiac surgery Completed 84
NCT05519189 Low Intervention Hemorrhoidal disease Completed 134
NCT06185608 Phase 3 Hallux valgus Authorised 174

FAQ

  • What are the clinical trials about Ropivacaine studying? They are studying pain control and recovery after procedures such as pleural drainage, throat and neck cancer surgery, cardiac sternotomy, hemorrhoid treatment, and hallux valgus repair.
  • Who may take part in these trials? The trials involve adults undergoing specific surgeries or procedures in intensive care or surgical settings. Each study has its own eligibility rules based on the condition and procedure.
  • What phases are these Ropivacaine trials in? Most of the studies listed are Phase 3 trials, which means they compare treatments in larger patient groups. One study is marked as Low Intervention rather than a standard phase.
  • What outcomes are being measured? The trials measure pain scores, morphine use after surgery, breathing function after chest surgery, and the duration of sensory block. These outcomes help show how well the study treatment works.
  • Are these trials only for one type of surgery? No. Ropivacaine is being studied in several different settings, including intensive care, cancer surgery, cardiac surgery, hemorrhoid procedures, and foot surgery.

Sperimentazioni cliniche in corso su Ropivacaine

  • Studio sull’uso di Ropivacaina e Sodio Cloruro per ridurre il dolore post-operatorio nei pazienti sottoposti a chirurgia per cancro alla gola e al collo

    In arruolamento

    1 1 1
    Farmaci in studio:
    Francia

  • Studio sugli effetti di diverse concentrazioni di ropivacaina nel blocco della caviglia guidato da ultrasuoni in pazienti sottoposti a chirurgia dell’alluce valgo

    In arruolamento

    1 1 1 1
    Farmaci in studio:
    Belgio

  • Studio randomizzato su volontari sani 18‑64 anni per valutare l’effetto sistemico di lidocaina cloridrato, ropivacaina e cloruro di sodio sul dolore acuto

    Arruolamento non iniziato

    1 1 1
    Farmaci in studio:
    Norvegia

  • Studio sull’uso di Ropivacaina, Lidocaina Cloridrato e Dexametasone Fosfato Sodico per il dolore acuto durante il drenaggio pleurico in terapia intensiva

    Arruolamento non iniziato

    1 1 1 1
    Farmaci in studio:
    Francia

  • Studio sull’effetto del blocco para-sternale con ropivacaina sulla funzione respiratoria post-operatoria nei pazienti sottoposti a chirurgia cardiaca.

    Arruolamento concluso

    1 1 1 1
    Farmaci in studio:
    Francia

  • Studio sull’uso di ropivacaina per il trattamento della malattia emorroidaria con radiofrequenza per pazienti adulti

    Arruolamento concluso

    1 1 1 1
    Malattie in studio:
    Farmaci in studio:
    Francia

Glossario

  • Trial clinico: Uno studio di ricerca che valuta se un trattamento funziona e quanto è sicuro in persone reali.
  • Phase 3: Una fase di studio su gruppi più grandi di pazienti per confrontare i risultati del trattamento.
  • Interventional: Uno studio in cui i partecipanti ricevono un trattamento o una procedura assegnata dai ricercatori.
  • Anestesia locoregionale: Una tecnica che blocca il dolore in una parte specifica del corpo invece di addormentare tutto il paziente.
  • Blocco nervoso: Una iniezione vicino ai nervi per ridurre il dolore in una zona del corpo.
  • Serratus plane block: Un tipo di blocco del dolore usato nella zona del torace, studiato durante il drenaggio pleurico.
  • Plexus cervicale superficiale: Un gruppo di nervi del collo che può essere bloccato per ridurre il dolore durante la chirurgia di testa e collo.
  • Sternotomia: Un taglio chirurgico nel torace, spesso usato per alcuni interventi cardiaci.
  • VAS: Scala visiva analogica: un punteggio usato per misurare quanto dolore sente il paziente.
  • FVC: Capacità vitale forzata: una misura di quanto aria una persona riesce a espirare con forza.
  • PCA: Patient-controlled analgesia: un sistema che permette al paziente di ricevere antidolorifico quando ne ha bisogno.
  • Blocco sensitivo: Perdita temporanea della sensibilità in una zona del corpo, usata per valutare quanto dura l’effetto del trattamento.

Riferimenti

  1. https://studi-clinici.it/studio/studio-sulluso-di-ropivacaina-lidocaina-cloridrato-e-dexametasone-fosfato-sodico-per-il-dolore-acuto-durante-il-drenaggio-pleurico-in-terapia-intensiva/
  2. https://clinicaltrials.gov/study/2024-510942-15-00
  3. https://clinicaltrials.gov/study/2024-513301-30-00
  4. https://studi-clinici.it/studio/studio-sulluso-di-ropivacaina-per-il-trattamento-della-malattia-emorroidaria-con-radiofrequenza-per-pazienti-adulti/
  5. https://studi-clinici.it/studio/effetti-di-diverse-concentrazioni-di-ropivacaina-sui-blocchi-alla-caviglia-guidati-da-ultrasuoni-in-pazienti-sottoposti-a-chirurgia-per-alluce-valgo/