Defining the Best Approach to Block the Pain After Knee Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00294073
Recruitment Status : Unknown
Verified August 2005 by McGill University Health Center.
Recruitment status was:  Recruiting
First Posted : February 20, 2006
Last Update Posted : June 19, 2007
Information provided by:
McGill University Health Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Procedure: Fascia Iliaca Block Procedure: Femoral Block (with stimulating catheter) Procedure: Femoral Block (without stimulating catheter) Phase 3

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Defining the Best Approach to Block the Pain After Knee Surgery
Study Start Date : July 2005

Primary Outcome Measures :
  1. 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 ]
  2. pain relief; measured by WOMAC [ Time Frame: before surgery and at days 7, 60, 90 ]
  3. pain relief; evaluated from standard datasheet [ Time Frame: over 48-hour period ]

Secondary Outcome Measures :
  1. knee range of bending [ Time Frame: measured before surgery, and at days 7, 60, 90 ]
  2. thigh circumference 20 cm above the knee [ Time Frame: measured before surgery and at days 7, 60, 90 ]
  3. neurological exam of femorocutaneous, femoral and obturator nerves [ Time Frame: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia ]
  4. level of activity; measured using questionnaire [ Time Frame: at 7-10 days and at 2 and 3 months ]
  5. need for rescue analgesia [ Time Frame: in recovery room and at home ]
  6. need for second bolus or crossing over between groups

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00294073

Contact: Juan F Asenjo, MD 514-934-1934 ext 43261

Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3G 1A4
Principal Investigator: Juan F Asenjo, MD         
Sponsors and Collaborators
McGill University Health Center
Principal Investigator: Juan F Asenjo, MD Montreal General Hospital

Publications: Identifier: NCT00294073     History of Changes
Other Study ID Numbers: GEN#05-002
First Posted: February 20, 2006    Key Record Dates
Last Update Posted: June 19, 2007
Last Verified: August 2005

Keywords provided by McGill University Health Center:
femoral block
fascia iliaca block
ACL repair
post-operative analgesia
knee surgery
ACL damage
knee damage

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms