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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00803348
First received: December 4, 2008
Last updated: April 25, 2012
Last verified: January 2010

December 4, 2008
April 25, 2012
May 2009
October 2011   (final data collection date for primary outcome measure)
Time to readiness to discharge from hospital [ Time Frame: Twice daily until discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00803348 on ClinicalTrials.gov Archive Site
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 [ Time Frame: Up to Month 6 post-operative ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Knee Arthroplasty
  • 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
  • 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
  • Drug: Saline control
    Bolus of 0.375% ropivicaine 30 mls followed by saline infusion until 0600 on postoperative day 2
  • Active Comparator: 1
    Initial Bolus dose of 0.2% ropivicaine followed by 0.2% ropivicaine infusion until day 2 post-op
    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
  • Experimental: 2
    Initial Bolus dose of 0.2% ropivicaine followed by 0.1% ropivicaine infusion until day 2 post-op
    Intervention: 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
  • Placebo Comparator: 3
    Initial Bolus dose of 0.375% ropivicaine followed by saline infusion until day 2 post-op
    Intervention: Drug: Saline control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00803348
08-0895-B
No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Richard Brull, MD University Health Network, Toronto
University Health Network, Toronto
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP