- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07688486
Clinical Pharmacist-Led Perioperative Pain Management in Orthopedic Surgery: An Effectiveness Evaluation
Clinical Pharmacist-Involved Perioperative Pain Management Model Construction and Effectiveness Evaluation in Orthopedic Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background and Rationale:
Postoperative pain management in orthopedic surgery remains a challenge, often complicated by polypharmacy and the risk of opioid-related adverse events. Clinical pharmacists possess specialized expertise in pharmacotherapy that can optimize analgesic regimens, reduce medication errors, and improve patient outcomes. However, standardized models for pharmacist-led perioperative care in orthopedics require further evaluation.
Study Design:
This is a prospective, single-center, randomized controlled trial (RCT). Eligible patients scheduled for elective orthopedic surgery (e.g., joint replacement, fracture fixation) will be recruited.
Interventions:
Participants will be randomly assigned (1:1 ratio) to one of two groups:
Control Group (Standard Care): Patients receive routine perioperative care managed by surgeons and nurses according to standard hospital protocols. Pain is assessed and treated based on physician orders without specific pharmacist intervention.
Intervention Group (Pharmacist-Led Care): Patients receive a structured pharmaceutical care program led by a clinical pharmacist. Key components include:
Preoperative: Comprehensive medication review and reconciliation to identify potential drug-drug interactions and high-risk medications. Patient education regarding pain management expectations.
Intraoperative: Collaboration with the anesthesia team to optimize multimodal analgesia strategies.
Postoperative: Daily ward rounds to assess pain scores and analgesic efficacy. Proactive recommendations for regimen adjustments (e.g., switching from IV to oral analgesics, adding adjuvant analgesics) to the surgical team. Monitoring for adverse drug reactions (e.g., nausea, constipation, sedation).
Discharge: Medication counseling and provision of a personalized pain management plan.
Outcome Measures:
Primary Outcome: Pain intensity assessed using the Visual Analog Scale (VAS) or Numeric Rating Scale (NRS) at rest and during movement at 24, 48, and 72 hours post-surgery.
Secondary Outcomes:
Total opioid consumption (converted to morphine milligram equivalents, MME) during the hospital stay.
Incidence of opioid-related adverse events (nausea, vomiting, constipation, respiratory depression).
Time to first ambulation. Length of hospital stay. Patient satisfaction with pain management (assessed via questionnaire at discharge).
Statistical Analysis:
Data will be analyzed using intention-to-treat principles. Continuous variables will be compared using t-tests or Mann-Whitney U tests, and categorical variables using Chi-square tests. A p-value of <0.05 will be considered statistically significant.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: qiniqn hu
- Numero di telefono: +8618867962215
- Email: chawml@zju.edu.cn
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
nclusion Criteria : Patients scheduled for elective orthopedic surgery (e.g., total hip/knee arthroplasty, fracture fixation).
Age ≥ 18 years. American Society of Anesthesiologists (ASA) physical status I-III. Able to understand and communicate pain intensity (e.g., use VAS score). Willing to provide informed consent.
Exclusion Criteria Emergency surgery or trauma patients unable to communicate. History of chronic opioid use or substance abuse. Severe cognitive impairment or psychiatric disorders preventing cooperation. Known allergy or contraindication to study medications (analgesics). Pregnant or breastfeeding women. Participation in other clinical trials that may interfere with this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Standard Care Group
Patients in this group will receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
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Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
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Sperimentale: Clinical Pharmacist-Led Intervention Group
Patients in this group will receive comprehensive pharmaceutical care led by a clinical pharmacist, including preoperative medication reconciliation, intraoperative monitoring, and postoperative analgesic optimization.
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Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Pain Intensity Score (Visual Analog Scale, VAS)
Lasso di tempo: Up to 72 hours post-operation
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Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
The score will be recorded at rest and during movement (e.g., coughing or rehabilitation exercises) at 6, 12, 24, 48, and 72 hours post-surgery.
The primary endpoint is the average VAS score at rest during the first 24 hours.
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Up to 72 hours post-operation
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KY-2026-036
- 10042 (Altro identificatore: National Health Commission Capacity Building and Continuing Education Center)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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