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NCT Number: NCT00803348

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

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.

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Key information

Conditions

Knee Arthroplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Drug

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

Drug

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

Primary outcomes

  1. Time to readiness to discharge from hospital

    Time frame: Twice daily until discharge

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 5, 2008
Registry last updated
Apr 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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