Clinical Pharmacist-Led Perioperative Pain Management in Orthopedic Surgery: An Effectiveness Evaluation

NCT07688486 | Not Yet Recruiting

• 2 other identifiers: KY-2026-03610042
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Care Group

ACTIVE COMPARATOR

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

Clinical Pharmacist-Led Intervention Group

EXPERIMENTAL

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

Interventions

Clinical Pharmacist-Led Pain Management OTHER

Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.

Clinical Pharmacist-Led Intervention Group

Standard Perioperative Care OTHER

Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

qiniqn hu

CONTACT

+8618867962215; chawml@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Both the participants and the investigators (clinical pharmacists) are aware of the group assignments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 7, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-04