Defining the Best Approach to Block the Pain After Knee Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by McGill University Health Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00294073
First received: February 17, 2006
Last updated: June 18, 2007
Last verified: August 2005
  Purpose

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 Intervention Phase
Pain, Postoperative
Procedure: Fascia Iliaca Block
Procedure: Femoral Block (with stimulating catheter)
Procedure: Femoral Block (without stimulating catheter)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Defining the Best Approach to Block the Pain After Knee Surgery

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 60
Study Start Date: July 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294073

Contacts
Contact: Juan F Asenjo, MD 514-934-1934 ext 43261 jfasenjog@yahoo.com

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

Publications:
ClinicalTrials.gov Identifier: NCT00294073     History of Changes
Other Study ID Numbers: GEN#05-002, REC#02-030
Study First Received: February 17, 2006
Last Updated: June 18, 2007
Health Authority: Canada: Ethics Review Committee

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
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014