Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Understanding pain management after orthopedic surgery

Official title: Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery

Run by University Health Network, Toronto · NCT04811209 · Data updated 2026-11-12

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 typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment300 (estimated)
SponsorUniversity Health Network, Toronto
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedJune 21, 2021
Main results expectedAugust 31, 2026
Study endsDecember 31, 2026
Registry record updatedJune 10, 2026
Trial IDNCT04811209 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with psychiatric disorders, chronic substance abuse issues, or those unable to provide informed consent may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.