Defining the Best Approach to Block the Pain After Knee Surgery - Full Text View

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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

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:

Morau D, Lopez S, Biboulet P, Bernard N, Amar J, Capdevila X. Comparison of continuous 3-in-1 and fascia Iliaca compartment blocks for postoperative analgesia: feasibility, catheter migration, distribution of sensory block, and analgesic efficacy. Reg Anesth Pain Med. 2003 Jul-Aug;28(4):309-14.

Salinas FV, Neal JM, Sueda LA, Kopacz DJ, Liu SS. Prospective comparison of continuous femoral nerve block with nonstimulating catheter placement versus stimulating catheter-guided perineural placement in volunteers. Reg Anesth Pain Med. 2004 May-Jun;29(3):212-20.

Williams BA, Kentor ML, Vogt MT, Vogt WB, Coley KC, Williams JP, Roberts MS, Chelly JE, Harner CD, Fu FH. Economics of nerve block pain management after anterior cruciate ligament reconstruction: potential hospital cost savings via associated postanesthesia care unit bypass and same-day discharge. Anesthesiology. 2004 Mar;100(3):697-706.

Eriksson E. Pain relief after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 May;12(3):179. Epub 2004 Apr 21. No abstract available.

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