Clinical trial NCT00294073: Defining the Best Approach to Block the Pain After Knee Surgery
Official title: Defining the Best Approach to Block the Pain After Knee Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Keywords: femoral block
fascia iliaca block
ACL repair
post-operative analgesia
knee surgery
ACL damage
knee damage
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pain relief; measured by VAS at rest and on activity
timeFrame: before surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90
measure: pain relief; measured by WOMAC
timeFrame: before surgery and at days 7, 60, 90
measure: pain relief; evaluated from standard datasheet
timeFrame: over 48-hour period
Secondary outcomes:
measure: knee range of bending
timeFrame: measured before surgery, and at days 7, 60, 90
measure: thigh circumference 20 cm above the knee
timeFrame: measured before surgery and at days 7, 60, 90
measure: neurological exam of femorocutaneous, femoral and obturator nerves
timeFrame: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
measure: level of activity; measured using questionnaire
timeFrame: at 7-10 days and at 2 and 3 months
measure: need for rescue analgesia
timeFrame: in recovery room and at home
measure: need for second bolus or crossing over between groups
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: Montreal General Hospital
name: Juan F Asenjo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s1098-7339(03)00183-4.
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. doi: 10.1016/j.rapm.2004.02.009.
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. doi: 10.1097/00000542-200403000-00034.
citation: Eriksson E. Pain relief after ACL reconstruction. Knee Surg Sports Traumatol Arthrosc. 2004 May;12(3):179. doi: 10.1007/s00167-004-0526-4. Epub 2004 Apr 21. No abstract available.