Defining the Best Approach to Block the Pain After Knee Surgery

Phase 3

• Conditions: Pain, Postoperative

• Registration Number: NCT00294073
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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 Timeline

• Study Start: 2005-07
• Status Verified: 2005-08
• Study First Submitted: 2006-02-17
• Study First Submitted QC: 2006-02-17
• Study First Posted: 2006-02-20
• Last Update Submitted: 2007-06-18
• Last Update Posted: 2007-06-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
pain relief; measured by VAS at rest and on activity	before surgery, before discharge from PACU and on 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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada