| February 17, 2006 |
| June 18, 2007 |
| July 2005 |
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- pain relief; measured by VAS at rest and on activity [ Time Frame: before surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90 ]
- pain relief; measured by WOMAC [ Time Frame: before surgery and at days 7, 60, 90 ]
- pain relief; evaluated from standard datasheet [ Time Frame: over 48-hour period ]
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- pain relief; measured by VAS at rest and on activity before surgery, before discharge from PACU and at evenings of days 1,2,7,60,90.
- pain relief; measured by WOMAC before surgery and at days 7,60,90.
- pain relief; evaluated from standard datasheet over 48-hour period.
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| Complete list of historical versions of study NCT00294073 on ClinicalTrials.gov Archive Site |
- knee range of bending [ Time Frame: measured before surgery, and at days 7, 60, 90 ]
- thigh circumference 20 cm above the knee [ Time Frame: measured before surgery and at days 7, 60, 90 ]
- neurological exam of femorocutaneous, femoral and obturator nerves [ Time Frame: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia ]
- level of activity; measured using questionnaire [ Time Frame: at 7-10 days and at 2 and 3 months ]
- need for rescue analgesia [ Time Frame: in recovery room and at home ]
- need for second bolus or crossing over between groups
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- knee range of bending; measured before surgery, and at days 7, 60, 90.
- thigh circumference 20 cm above the knee; measured before surgery and at days 7, 60, 90.
- neurological exam of femorocutaneous, femoral and obturator nerves; evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia.
- level of activity; measured using questionnaire, at 7-10 days and at 2 and 3 months.
- need for rescue analgesia; in recovery room and at home.
- need for second bolus or crossing over between groups.
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| Defining the Best Approach to Block the Pain After Knee Surgery |
| Defining the Best Approach to Block the Pain After Knee Surgery |
The study aims to compare standard techniques used to control pain after knee surgery. The investigators hypothesize that the fascia iliaca block is faster, safer and as good as or better than the femoral block, with or without a stimulating catheter. |
60 patients being treated for ACL repair or knee arthroplasties under regional anesthesia will be randomized to three groups: Fascia Iliaca Block (FIB), Femoral Block (FB) with stimulating catheter or FB without stimulating catheter. A catheter will be placed according to each technique, before the surgery. A bolus of local anesthetic will be given pre-surgery and at the end of the operation, in all groups. A continuous infusion will be started for 48 hours. All patients receive a standard analgesia cocktail and rescue medication.
Pain and level of activity, as well as side effects, will be evaluated. |
| Phase III |
| Interventional |
| Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Pain, Postoperative |
- Procedure: Fascia Iliaca Block
- Procedure: Femoral Block (with stimulating catheter)
- Procedure: Femoral Block (without stimulating catheter)
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| |
- Morau D, Lopez S, Biboulet P, Bernard N, Amar J, Capdevila X. Comparison of continuous 3-in-1 and fascia Iliaca compartment blocks for postoperative analgesia: feasibility, catheter migration, distribution of sensory block, and analgesic efficacy. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):309-14.
- Salinas FV, Neal JM, Sueda LA, Kopacz DJ, Liu SS. Prospective comparison of continuous femoral nerve block with nonstimulating catheter placement versus stimulating catheter-guided perineural placement in volunteers. Reg Anesth Pain Med. 2004 May-Jun;29(3):212-20.
- Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706.
- Eriksson E. Pain relief after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 May;12(3):179. Epub 2004 Apr 21. No abstract available.
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| Recruiting |
| 60 |
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Inclusion Criteria:
- Patients coming for ACL or knee prosthesis surgery
- Between 18-80 years old
- Consenting for spinal anesthesia
Exclusion Criteria:
- Major neurologic diseases
- Obesity with body mass index (BMI) > 30
- Infection at the punction sites (back and/or groin)
- Diabetes mellitus for longer than 5 years
- Coagulopathy
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| Both |
| 18 Years to 80 Years |
| No |
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| Canada |
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| NCT00294073 |
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| GEN#05-002, REC#02-030 |
| McGill University Health Center |
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| Principal Investigator: |
Juan F Asenjo, MD |
Montreal General Hospital |
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| McGill University Health Center |
| August 2005 |