Clinical Trials Directory

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CompletedNCT03647709

Opioid-free Accelerated Recovery Total Knee Arthroplasty

Opioid-Free Accelerated Recovery Total Knee Arthroplasty

Status
Completed
Phase
Study type
Observational
Enrollment
400 (actual)
Sponsor
St. Elizabeth Medical Center, Utica, NY · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.

Detailed description

All study patients will receive a standardized protocol * All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center * Will attempt to minimize the number of anesthesiologists to further control variability in care Methods: 1. Pre-op Optimization * All patients enroll in education program * All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure 2. Total Joint Procedure * Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block 3. Data Collection * Electronic medical record chart review * Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge * Phone calls after discharge * Follow-up assessment in surgeon's office * Swift path / KOOS JR surveys 4. Pain Management Regimen * pre-op physical therapy teaching * post-op multimodal pain regimen

Conditions

Interventions

TypeNameDescription
OTHERopioidsdosage frequency and duration

Timeline

Start date
2018-10-01
Primary completion
2019-10-30
Completion
2020-04-30
First posted
2018-08-27
Last updated
2020-05-12
Results posted
2020-05-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03647709. Inclusion in this directory is not an endorsement.