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Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?

NCT ID: NCT03038425

Last Updated: 2020-12-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-02

Study Completion Date

2020-04-01

Brief Summary

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This is a randomized, double-blinded pilot study to determine whether patients undergoing ambulatory total knee arthroplasty (TKA) using a subvastus approach benefit from the addition of a continuous adductor canal nerve block (cACB) catheter along with an existing multimodal approach to postoperative analgesia. Outcomes include the 15-item Quality of Recovery Scale (QoR-15) (Miles 2016), pain scores, opioid consumption, opioid-free days, functional outcome as measured by the Time Up and Go (TUG) test, patient satisfaction, patient's rating of catheter effectiveness, and complications.

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee Nerve Block Anesthesia, Regional Ambulatory Surgical Procedures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline infusion

Participants in this group will receive normal saline infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect

Ropivacaine infusion

Participants in this group will receive ropivacaine 0.2% infusion (5ml/hr, patient controlled bolus 5ml, lockout 30min) in the adductor canal, starting in PACU on post-operative day 0 and continuing for 96 hours

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA

Interventions

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Normal Saline

This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect

Intervention Type DRUG

Ropivacaine

This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. patient characteristics suitable for subvastus approach as determined by single surgeon
2. patients willing to undergo ambulatory surgery
3. ability to read and verbally communicate via either English or French

Exclusion Criteria

1. age \> 80
2. driving distance greater than 1 hour from hospital
3. no willing caregiver at home on night of surgery
4. renal failure requiring dialysis
5. Insulin-dependent diabetes mellitus
6. BMI \> 45
7. allergy to study medications
8. pre-existing neurologic deficit involving the ipsilateral limb
9. chronic high dose opioid use (defined as \>200mg/day of morphine equivalent for over 2 weeks).
10. inability to use or manage cACB catheter and pump independently at home
11. inability or refusal to cryocompressive therapy device.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ottawa Hospital Academic Medical Association

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick BY Wong, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital, University of Ottawa

Locations

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The Ottawa Hospital, General Campus

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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20160937

Identifier Type: -

Identifier Source: org_study_id