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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Other: Standard Perioperative Care; Other: Clinical Pharmacist-Led Pain Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: qiniqn hu; Phone Number: +8618867962215; Email: chawml@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Standard Perioperative Care; Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
Experimental: 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.	Other: Clinical Pharmacist-Led Pain Management; Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Score (Visual Analog Scale, VAS)	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

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 1, 2026
• First Posted (Actual): July 7, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative
• Other Study ID Numbers: KY-2026-036; 10042 (Other Identifier: National Health Commission Capacity Building and Continuing Education Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No