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

NCT03038425 | Completed DMC

• 1 other identifier: 20160937
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery Scale 15 (QoR-15)

  QoR-15 is a validated scale calculated from a 15-question patient questionnaire. It is an aggregate score that evaluates recovery after surgery.

  at 4pm on post-operative day (POD) 1

Secondary Outcomes (10)

• Quality of Recovery Scale 15 (QoR-15)

  POD 2-4 + 7

• Pain score at rest

  POD 1-4 + 7

• Pain score with activity

  POD 1-4 + 7

• Tapentadol consumption

  POD 1-4 + 7

• Patient satisfaction

  POD 1-4 + 7

Study Arms (2)

Saline infusion

PLACEBO COMPARATOR

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

Drug: Normal Saline

Ropivacaine infusion

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Normal Saline DRUG

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

Saline infusion

Ropivacaine 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

Ropivacaine infusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• The Ottawa Hospital Academic Medical Association: collaborator

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Interventions

Saline Solution; Ropivacaine

Intervention Hierarchy (Ancestors)

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

Study Officials

• Patrick BY Wong, MD

  The Ottawa Hospital, University of Ottawa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 31, 2017
• Study Start: May 2, 2017
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Locations

CA (1)