Defining the Best Approach to Block the Pain After Knee Surgery

Pain, Postoperative Clinical Trial

Official title:

Defining the Best Approach to Block the Pain After Knee Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00294073
• Other study ID #: GEN#05-002
• Secondary ID: REC#02-030
• Status: Recruiting
• Phase: Phase 3
• First received: February 17, 2006
• Last updated: June 18, 2007
• Start date: July 2005

Study information

• Verified date: August 2005
• Source: McGill University Health Center
• Contact: Juan F Asenjo, MD
• Phone: 514-934-1934
• Email: jfasenjog[@]yahoo.com
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• Fascia Iliaca Block

• Femoral Block (with stimulating catheter)

• Femoral Block (without stimulating catheter)

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Eriksson E. Pain relief after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 May;12(3):179. Epub 2004 Apr 21. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	pain relief; measured by WOMAC		before surgery and at days 7, 60, 90
Primary	pain relief; evaluated from standard datasheet		over 48-hour period
Secondary	knee range of bending		measured before surgery, and at days 7, 60, 90
Secondary	thigh circumference 20 cm above the knee		measured before surgery and at days 7, 60, 90
Secondary	neurological exam of femorocutaneous, femoral and obturator nerves		evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
Secondary	level of activity; measured using questionnaire		at 7-10 days and at 2 and 3 months
Secondary	need for rescue analgesia		in recovery room and at home
Secondary	need for second bolus or crossing over between groups