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Defining the Best Approach to Block the Pain After Knee Surgery
This study is currently recruiting participants.
Study NCT00294073   Information provided by McGill University Health Center
First Received: February 17, 2006   Last Updated: June 18, 2007   History of Changes

February 17, 2006
June 18, 2007
July 2005
 
  • 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 ]
  • 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.
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
  • 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.
 
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)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
60
 
 

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
Both
18 Years to 80 Years
No
Contact: Juan F Asenjo, MD 514-934-1934 ext 43261 jfasenjog@yahoo.com
Canada
 
NCT00294073
 
GEN#05-002, REC#02-030
McGill University Health Center
 
Principal Investigator: Juan F Asenjo, MD Montreal General Hospital
McGill University Health Center
August 2005

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