Clinical trial
Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty: Quality Of Recovery Through Patient Reporting - a Multisite Study
Name
TRUE KnORTH 2.0
Description
To assess postoperative patient-reported quality of recovery after total knee arthroplasty (TKA) with periarticular joint injection (PAI) ± single shot adductor canal block with or without adductor canal catheter infusion.
Trial arms
Trial start
2024-07-01
Estimated PCD
2026-03-31
Trial end
2026-06-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
Ropivacaine
800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)
Arms:
cACB active
Normal saline
400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)
Arms:
cACB sham
Size
226
Primary endpoint
Quality of Recovery-15 Survey scores
Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3
Eligibility criteria
Inclusion Criteria:
* All adult patients presenting for a primary TKA.
Exclusion Criteria:
* Age \<18 years;
* Body mass index ≥45 kg/m2;
* Weight \<80 kg;
* Deemed unsuitable for regional anesthesia;
* Planned general anesthesia;
* Hepatic insufficiency/Intolerance to acetaminophen;
* Renal insufficiency (defined by estimated glomerular filtration rate \<60 mL/min/1.73 m2);
* Chronic opioid use (individuals requiring the equivalent of 1 mg or more of intravenous morphine, or 3 mg or more of oral morphine per hour for greater than 1 month);
* Allergy or intolerance to study medications (listed under 'Spinal and Adductor Canal Block') or trial medications listed in "Postoperative" section and "standard prescription"
* Clinical Frailty Scale score ≥4;
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'Pharmacy will have access to the randomization scheme. All other members of the study team are blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 226, 'type': 'ESTIMATED'}}
Updated at
2024-01-17
1 organization
2 products
3 indications
Organization
McMaster UniversityProduct
RopivacaineIndication
ArthroplastyIndication
ReplacementIndication
KneeProduct
Normal saline