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

Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803348
• Other study ID #: 08-0895-B
• Status: Completed
• Phase: N/A
• First received: December 4, 2008
• Last updated: April 25, 2012
• Start date: May 2009
• Est. completion date: October 2011

Study information

• Verified date: January 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian REB
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

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
• 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
• Saline control
Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to readiness to discharge from hospital		Twice daily until discharge	No
Secondary	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	No