Understanding pain management after orthopedic surgery
Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery
University Health Network, Toronto · NCT04811209
This study is trying to find out how much pain relief is needed after major orthopedic surgeries to help patients feel comfortable and recover better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04811209 on ClinicalTrials.gov |
What this trial studies
This observational study aims to define the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for patients undergoing various elective major orthopedic surgeries. It focuses on assessing acute postoperative pain, which affects a significant portion of surgical patients, and seeks to establish valid MCID values specific to acute pain rather than relying on chronic pain data. The study will utilize both anchor-based and distribution-based methods to evaluate patient-reported outcomes related to pain relief. By improving pain assessment, the study aims to enhance analgesic therapy and overall recovery for patients.
Who should consider this trial
Good fit: Ideal candidates include adult patients aged 18-80 who are undergoing primary elective major orthopedic surgeries such as total hip or knee replacements.
Not a fit: Patients with psychiatric disorders, chronic substance abuse issues, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective pain management strategies for patients undergoing orthopedic surgery.
How similar studies have performed: While there have been studies on chronic pain MCID values, this approach to defining MCID for acute postoperative pain is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients aged 18-80 years * ASA class I - III * Primary elective surgery * unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures: * unilateral total hip replacement * unilateral total knee replacement, and * spinal decompression + fusion involving ≥ 2 levels. * Hospital admission for ≥ 24 hours after the surgery Exclusion Criteria: * Inability to give informed consent * Poor English comprehension * Psychiatric disorders e.g., dementia * Known allergies to morphine / hydromorphone * Chronic substance abuse and use of recreational drugs * Any medical disorder that impairs accurate and objective completion of questionnaires
Where this trial is running
Toronto, Ontario
- Toronto Western Hopspital — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Anahi Perlas, MD, FRCPC — University Health Network, Toronto
- Study coordinator: Jayanta Chowdhury, MBBS,MD
- Email: jayanta.chowdhury@uhn.ca
- Phone: 4166035800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pain Management