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

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

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.

Study Overview

• Status: Completed
• 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

• Study Type: Interventional
• Enrollment (Actual): 99
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. ASA physical status I-III
2. 18-85 years of age, inclusive
3. Able to communicate in English sufficiently to participate in the study
4. Able to walk 30 metres without stopping prior to surgery

Exclusion Criteria:

1. Intended discharge to in-patient rehabilitation facility
2. Patient refusal of FNB or spinal anesthetic or sciatic nerve block
3. Contraindications to peripheral nerve block (e.g. allergy to local anesthetics, refusal)
4. Significant peripheral neuropathy or neurological disorder affecting the lower extremity
5. Contraindication to a component of multi-modal analgesia
6. Pregnancy
7. History of use of over 30mg oxycodone or equivalent per day (institutional threshold for acute pain service consultation pre-operatively)
8. History of significant cognitive or psychiatric condition that may affect patient assessment
9. Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 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; 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
Experimental: 2; 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; 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
Placebo Comparator: 3; Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op	Drug: Saline control; Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Richard Brull, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• Albrecht E, Morfey D, Chan V, Gandhi R, Koshkin A, Chin KJ, Robinson S, Frascarolo P, Brull R. Single-injection or continuous femoral nerve block for total knee arthroplasty? Clin Orthop Relat Res. 2014 May;472(5):1384-93. doi: 10.1007/s11999-013-3192-3.

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: December 4, 2008
• First Submitted That Met QC Criteria: December 4, 2008
• First Posted (Estimate): December 5, 2008

Study Record Updates

• Last Update Posted (Estimate): April 26, 2012
• Last Update Submitted That Met QC Criteria: April 25, 2012
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: knee replacement; knee arthroplasty; regional anesthesia; continuous femoral nerve blockade; readiness to discharge; Femoral nerve blockade for total knee arthroplasty
• Other Study ID Numbers: 08-0895-B