Analgesia Clinical Trial
Official title:
Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing
This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.
Status | Recruiting |
Enrollment | 142 |
Est. completion date | September 30, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Primary unilateral TKA under spinal anesthesia at Brigham & Women's Faulkner Hospital (BWFH), Brigham and Women's Hospital or University of Chicago Medical Center by a participating surgeon - >18 years of age - Planned discharge with the typical analgesic medications prescribed at discharge: - standing around-the clock Tylenol with or without an NSAID - tramadol PRN - hydromorphone (dilaudid) or oxycodone PRN Exclusion Criteria: - Diagnosis of dementia - <18 years old - Contraindication or allergy to opioids - Contraindication or allergy to Tylenol - Contraindication or allergy to gabapentin - History of substance use disorder - Preoperative pain requiring a >1-month prescription for >/=45 daily MMEs - 4 or more preoperative analgesic prescriptions - Hospital admission >1 day - Discharge to a skilled nursing facility/inpatient rehabilitation center - Non-English speaking patients - Requirement for general anesthesia intra-operatively |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | University of Chicago Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Leftover opioid pills | 30 days postoperatively | ||
Primary | Average 0-10 NRS pain score | postoperative day 7 | ||
Secondary | Quantity of opioid consumed | 30 days postoperatively | ||
Secondary | Satisfaction with pain management | 30 days postoperatively | ||
Secondary | Quantity of opioid pills prescribed | postoperative day 1 at hospital discharge |
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