Postoperative Pain
Conditions
Brief summary
This study aims to evaluate the effectiveness of a clinical pharmacist-led perioperative pain management model in orthopedic surgery. It is a randomized controlled trial involving patients undergoing major orthopedic procedures. Participants will be assigned to either a standard care group or an intervention group receiving comprehensive pharmaceutical care, including preoperative medication reconciliation, intraoperative monitoring, and postoperative analgesic optimization. The primary outcome is the incidence of moderate-to-severe postoperative pain. Secondary outcomes include opioid consumption, adverse drug reactions, and patient satisfaction. This study seeks to establish an evidence-based protocol for optimizing pain management in orthopedic settings.
Detailed description
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.
Interventions
OTHERClinical Pharmacist-Led Pain Management
Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.
Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Both the participants and the investigators (clinical pharmacists) are aware of the group assignments.
Intervention model description
This is a randomized, parallel-group, controlled trial. Participants will be allocated to either the standard care group or the clinical pharmacist-led intervention group in a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity Score (Visual Analog Scale, VAS) | 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. |
Contacts
CONTACTqiniqn hu
Outcome results
None listed