- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: qiniqn hu
- Telefonnummer: +8618867962215
- E-mail: chawml@zju.edu.cn
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
|
|
Eksperimentel: 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.
|
Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain Intensity Score (Visual Analog Scale, VAS)
Tidsramme: Up to 72 hours post-operation
|
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.
|
Up to 72 hours post-operation
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KY-2026-036
- 10042 (Anden identifikator: National Health Commission Capacity Building and Continuing Education Center)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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