Clinical trial NCT00803348: Continuous Femoral Nerve Blockade and Readiness to Discharge Following Total Knee Arthroplasty
Official title: The Secret Recipe for Femoral Nerve Blockade After Total Knee Arthroplasty: A Randomized, Placebo-controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Arthroplasty
Keywords: continuous femoral nerve blockade
knee arthroplasty
knee replacement
regional anesthesia
readiness to discharge
Femoral nerve blockade for total knee arthroplasty
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-12-05
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to readiness to discharge from hospital
timeFrame: Twice daily until discharge
Secondary outcomes:
measure: 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
timeFrame: Up to Month 6 post-operative
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Richard Brull, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.