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

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT03038425
• Collaborator: The Ottawa Hospital Academic Medical Association (Other)
• Enrollment: 81
• Location: 1
• Arms: 2
• Actual Duration (Months): 35
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee; Nerve Block; Anesthesia, Regional; Ambulatory Surgical Procedures	Drug: Normal Saline; Drug: Ropivacaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Does Continuous Adductor Canal Nerve Block Improve the Quality of Recovery for Outpatient Total Knee Arthroplasty Patients?
• Actual Study Start Date: May 2, 2017
• Actual Primary Completion Date: Apr 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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	Drug: Normal Saline; This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
Active Comparator: 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	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

Outcome Measures

Primary Outcome Measures

1. Quality of Recovery Scale 15 (QoR-15) [at 4pm on post-operative day (POD) 1]

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

Secondary Outcome Measures

1. Quality of Recovery Scale 15 (QoR-15) [POD 2-4 + 7]

2. Pain score at rest [POD 1-4 + 7]

   Patients will rate their pain on a scale of 0-10

3. Pain score with activity [POD 1-4 + 7]

   Patients will rate their pain on a scale of 0-10

4. Tapentadol consumption [POD 1-4 + 7]

   Daily tapentadol use in milligrams

5. Patient satisfaction [POD 1-4 + 7]

   Patients will be asked "are you satisfied with your pain control"

6. Vital signs - blood pressure, heart rate, oxygen saturation [twice daily POD 1-4]

   These measurements will be obtained via post-operative home monitoring system

7. Patient-rated catheter effectiveness [POD 1-4]

   Patients will be asked "do you think the nerve block catheter is helpful? Rate on a 5-point scale"

8. Catheter specific complications [POD 1-4]

   Patients will be asked daily to report these potential nerve block catheter related issues: (1) leakage around the dressing (2) occlusion/blockage of the pump (3) inadvertent catheter disconnection (4) swelling around the catheter site (5) bleeding or bruising around the catheter site (6) other complications

9. Peri-operative complications [POD 30]

   Significant peri-operative complications resulting in return to emergency department, re-admission after discharge, or return to operating room will be reported

10. Timed-up-and-go (TUG) test [POD 14]

    TUG is a validated test to assess a person's mobility. It has been used to evaluate functional recovery after orthopedic surgeries. This will be administered on POD 14 at the surgeon's office during the post-operative follow-up visit

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ottawa Hospital, General Campus	Ottawa	Ontario	Canada	K1H 8L6

Sponsors and Collaborators

• Ottawa Hospital Research Institute
• The Ottawa Hospital Academic Medical Association

Investigators

• Principal Investigator: Patrick BY Wong, MD, The Ottawa Hospital, University of Ottawa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT03038425
• Other Study ID Numbers: 20160937
• First Posted: Jan 31, 2017
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Ropivacaine

Study Results

No Results Posted as of Dec 22, 2020