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NCT04811209
MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
Conditions: Pain Management
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 300
Sponsor: University Health Network, Toronto
Location: Toronto Western Hopspital Toronto Ontario
Summary
This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.
Eligibility 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
Source: ClinicalTrials.gov (NCT04811209). StuddyBuddy aggregates publicly available trial information.