Incidence of Chronic Pain in Patients Undergoing Knee Arthroplasty Within a Fast-Track Protocol

NCT07673276 | Active Not Recruiting

• 2 other identifiers: ONZ-2024-036019288
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about pain after knee replacement surgery. The surgery uses a fast-recovery program called Enhanced Recovery After Surgery (ERAS). The main questions are: How many participants still have pain three months after surgery? How severe is the pain? How many participants still use strong pain medication (opioids)? Participants are adults undergoing knee replacement surgery at UZ Gent and following the ERAS program. Researchers will collect information on pain and recovery before surgery and for up to three months afterward. Participants will answer simple questions about their pain and daily activities. This study will help researchers understand post-surgical recovery and may help improve pain care in the future.

Conditions

Chronic Post Surgical Pain; Functional Recovery; ERAS; Chronic Opioid Use; Inthrathecal Morfine; Knee Arthroplasty

Keywords

ERAS; CPSP; Functional recovery; Knee Arthroplasty

Outcome Measures

Primary Outcomes (4)

• Chronic postoperative pain (CPSP) at three months after knee arthroplasty

  Pain intensity will be assessed using the Numeric Rating Scale (NRS) during movement. CPSP will be defined as an NRS score ≥4 at three months postoperatively. Severe chronic postoperative pain will be defined as an NRS score ≥6. Unit of Measure: Points on an 0-10 Numeric Rating Scale.

  Three months after knee arthroplasty

• Functional recovery at 3 months after knee replacement

  Functional recovery will be assessed using the Oxford Knee Score (OKS). A score ≤14 indicates a poor functional outcome related to knee pain. Unit of Measure: Points on the Oxford Knee Score (0-48)

  3 months postoperatively

• Neuropathic pain characteristics at 3 months

  Neuropathic pain features will be evaluated using the DN4 questionnaire. A DN4 score ≥4 is considered suggestive of neuropathic pain. Unit of Measure: Points on the DN4 questionnaire (0-10).

  3 months postoperatively

• Postoperative opioid use at 3 months

  Postoperative opioid use will be assessed by recording whether participants use opioid medication and, if applicable, the amount of opioid medication used. Unit: Number of participants using opioids (yes/no) and/or morphine milligram equivalents (MME).

  3 months postoperatively

Secondary Outcomes (5)

• Postoperative pain intensity during hospital stay after knee arthroplasty

  Postoperative day 1 and day 2 after knee arthroplasty

• Preoperative and discharge pain intensity after knee arthroplasty

  Preoperatively and at postoperative day 1-2-3-4 (at hospital discharge)

• Opioid consumption during the perioperative period

  Perioperative period through postoperative day 1-2-3 (at hospital discharge)

• Surgical complications after knee arthroplasty

  From surgery until three months postoperatively

• Length of hospital stay after knee arthroplasty

  Postoperative day 1-2-3-4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients for whom a knee replacement is planned by a surgeon at our hospital and who are eligible for the fast-track program.

You may qualify if:

• All patients suitable for a standardized approach to the primary elective knee arthroplasty surgery and recovery period.

You may not qualify if:

• Significant comorbidities that may cause complications during the operation or the recovery period (e.g., heart and lung diseases, severe kidney disease, severe overweight).
• Severe neurological, physical, mental, and/or cognitive conditions that may complicate rehabilitation (e.g., inability to understand or follow postoperative instructions).
• Active infections or septic arthritis.
• Specific surgical obstacles such as revision surgery, extensive previous joint surgery, severe limitations in movement, severe instability, or marked abnormalities.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Patrick Wouters, Prof. Dr.

  University Hospital, Ghent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 29, 2026
• Study Start: February 24, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)