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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00803348
Other study ID # 08-0895-B
Secondary ID
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


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
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