Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Patients undergoing total knee arthroscopy (knee replacement) surgery usually receive a femoral nerve block as part of their anesthetic care. Some centers administer the block with a single shot of local anesthetic, which wears off several hours after surgery. Other centers administer the block with a single shot followed by continuous infusion of local anesthetic, typically for 2 to 5 days after surgery. The latter method, though good for pain control, may result in decreased mobility (while the anesthetic is still active), longer hospital stays, and greater risk of falls. This study will see if using a lower concentration of local anesthetic for the continuous femoral nerve block or only the initial single-shot dose will result in increased mobility and shorter hospital stays.

Official Title
-----------------
The Secret Recipe for Femoral Nerve Blockade After Total Knee Arthroplasty: A Randomized, Placebo-controlled, Double-blind Trial

Conditions
-----------------
Knee Arthroplasty

Intervention / Treatment
-----------------
* Drug: Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2
* Drug: Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2
* Drug: Saline control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I-III 18-85 years of age, inclusive Able to communicate in English sufficiently to participate in the study Able to walk 30 metres without stopping prior to surgery Exclusion Criteria: Intended discharge to in-patient rehabilitation facility Patient refusal of FNB or spinal anesthetic or sciatic nerve block Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal) Significant peripheral neuropathy or neurological disorder affecting the lower extremity Contraindication to a component of multi-modal analgesia Pregnancy History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively) History of significant cognitive or psychiatric condition that may affect patient assessment Inability to provide informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Initial Bolus dose of 0.2% ropivicaine followed by 0.2% ropivicaine infusion until day 2 post-op | Drug: Bolus of 0.2% ropivicaine 20 mls followed by 0.2% ropivicaine at an infusion rate of 5mls/hr until 0600 on postoperative day 2<br>* Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.2% ropivicaine at an infusion rate of 5mls/hr with patient controlled boluses of 5ml available every 30 mins, until 0600 on the morning of postoperative day 2<br>|
| Experimental: 2<br>Initial Bolus dose of 0.2% ropivicaine followed by 0.1% ropivicaine infusion until day 2 post-op | Drug: Bolus of 0.2% ropivicaine 20 mls followed by 0.1% ropivicaine at an infusion rate of 10mls/hr until 0600 on post-operative day 2<br>* Initial bolus of 0.2% ropivicaine 20 mls into the femoral catheter followed by 0.1% ropivicaine at an infusion rate of 10mls/hr with patient controlled boluses of 10mls available every 30 mins, until 0600 on the morning of postoperative day 2<br>|
| Placebo Comparator: 3<br>Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op | Drug: Saline control<br>* Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to readiness to discharge from hospital |  | Twice daily until discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadriceps strength, knee flexion, walking distance, pain, patient satisfaction, opioid consumption, adverse events, incidence of falls, volume of local anesthetic administered, block success, discharge date, functional recovery |  | Up to Month 6 post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
continuous femoral nerve blockade, knee arthroplasty, knee replacement, regional anesthesia, readiness to discharge, Femoral nerve blockade for total knee arthroplasty