Defining the Best Approach to Block the Pain After Knee Surgery

June 18, 2007 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Recruiting
        • Montreal General Hospital
        • Principal Investigator:
          • Juan F Asenjo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
before surgery and at days 7, 60, 90
pain relief; evaluated from standard datasheet
Time Frame: over 48-hour period
over 48-hour period

Secondary Outcome Measures

Outcome Measure
Time Frame
knee range of bending
Time Frame: measured before surgery, and at days 7, 60, 90
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
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
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
at 7-10 days and at 2 and 3 months
need for rescue analgesia
Time Frame: in recovery room and at home
in recovery room and at home
need for second bolus or crossing over between groups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Juan F Asenjo, MD, Montreal General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Study Registration Dates

First Submitted

February 17, 2006

First Submitted That Met QC Criteria

February 17, 2006

First Posted (Estimate)

February 20, 2006

Study Record Updates

Last Update Posted (Estimate)

June 19, 2007

Last Update Submitted That Met QC Criteria

June 18, 2007

Last Verified

August 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN#05-002
  • REC#02-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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