Postoperative PainNCT07688486
Clinical Pharmacist-Led Perioperative Pain Management in Orthopedic Surgery: An Effectiveness Evaluation
A study testing Clinical Pharmacist-Led Pain Management and Standard Perioperative Care in people with Postoperative Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Clinical Pharmacist-Led Pain Management and Standard Perioperative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Clinical Pharmacist-Led Pain Management, Standard Perioperative Care
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pharmacist-Led Pain ManagementOther
Description: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization.
Standard Perioperative CareOther
Patients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Clinical Pharmacist-Led Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688486
- Sponsor's protocol ID
- KY-2026-036
- Other IDs
- 10042
- Status last verified
- Apr 2026
- First submitted
- 1 Jul 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacist-Involved Perioperative Pain Management Model Construction and Effectiveness Evaluation in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07688486
- Acronym / sponsor ID
- KY-2026-036
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard Care Group | Active comparator | Other: Standard Perioperative CarePatients in this group will receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention. |
| Clinical Pharmacist-Led Intervention Group | Experimental | Other: Clinical Pharmacist-Led Pain ManagementPatients in this group will receive comprehensive pharmaceutical care led by a clinical pharmacist, including preoperative medication reconciliation, intraoperative monitoring, and postoperative analgesic optimization. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Pharmacist-Led Pain ManagementDescription: Comprehensive pharmaceutical care including medication reconciliation, patient education, and analgesic regimen optimization. | Other | Clinical Pharmacist-Led Intervention Group |
| Standard Perioperative CarePatients receive standard orthopedic perioperative care and routine pain management protocols as per hospital guidelines, without clinical pharmacist intervention. | Other | Standard Care Group |
Primary outcome
Pain Intensity Score (Visual Analog Scale, VAS)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Pharmacist-Led Pain Management and Standard Perioperative Care in people with Postoperative Pain, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qiniqn hu (+8618867962215, chawml@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity Score (Visual Analog Scale, VAS) (time frame: Up to 72 hours post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.