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

NCT ID: NCT06054750

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Knee osteoarthritis (KOA) is a leading cause of chronic knee pain and disability, with a lifetime prevalence of 45%. Treatment for symptomatic KOA includes physical therapy, oral anti-inflammatory medications and intra-articular steroid injections, with total knee arthroplasty (TKA) (or knee replacement) as the definitive treatment. Acute postoperative pain is common after TKA, leading to increased opioid consumption and increased hospital length of stay. Pain control following TKA has been investigated with interventions such as intrathecal morphine, nerve blocks, and periarticular joint injection (PAI). PAI and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing TKA. The aim of this study is to assess postoperative patient-reported quality of recovery after TKA with PAI and single shot adductor canal block with or without adductor canal catheter infusion.

Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Pharmacy will have access to the randomization scheme. All other members of the study team are blinded.

Study Groups

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cACB active

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

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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

cACB sham

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

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

Interventions

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Ropivacaine

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

Intervention Type DRUG

Normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Kim Wong, MD

Role: CONTACT

705-507-8208

Facility Contacts

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Toni Tidy, BHSc CCRA

Role: primary

905-525-9140 ext. 21737

Kim Wong, MD

Role: backup

Other Identifiers

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TRUE KnORTH 2.0

Identifier Type: -

Identifier Source: org_study_id

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