Testing Regional anesthesia Techniques For Up And Early Discharge Following Knee arthroplasty - a Feasibility Study

NCT06054750 | Not Yet Recruiting Phase 4

• 1 other identifier: TRUE KnORTH 2.0
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

To assess feasibility of a a trial investigation 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.

Conditions

Arthroplasty, Replacement, Knee

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery-15 Survey scores

  Patient-reported Quality of Recovery scores, where higher scores indicate better quality of recovery

  Postoperative day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3

Secondary Outcomes (11)

• Quality of Recovery-15 Survey scores

  Postoperative days 10 and 42

• Brief Pain Inventory - Pain Interference scores

  Postoperative days 1, 2 and 3 in the morning

• Pain Numerical Rating Scale at rest

  Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3

• Pain Numerical Rating Scale with activity

  Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy

• Functional Recovery: Range of motion

  Postoperative Day 0 (2 hours postoperatively), and morning of postoperative days 1, 2 and 3 after physiotherapy

Study Arms (2)

cACB active

EXPERIMENTAL

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (medication)

Drug: Ropivacaine

cACB sham

PLACEBO COMPARATOR

Periarticular joint injection (medication) + single shot adductor canal block (medication) + adductor canal catheter infusion (normal saline)

Drug: Normal saline

Interventions

Ropivacaine DRUG

800 mg ropivacaine in continuous infusion adductor canal block (400 mL total volume)

cACB active

Normal saline DRUG

400 mL normal saline in continuous infusion adductor canal block (400 mL total volume)

cACB sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients presenting for a primary TKA.

You may not qualify if:

• 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;

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

St Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Interventions

Ropivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Kim Wong, MD

CONTACT

705-507-8208

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will have access to the randomization scheme. All other members of the study team are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 26, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 22, 2024

Record last verified: 2024-09

Locations

CA (1)