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Defining the Best Approach to Block the Pain After Knee Surgery

Defining the Best Approach to Block the Pain After Knee Surgery

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00294073
Enrollment
60
Registered
2006-02-20
Start date
2005-07-31
Completion date
Unknown
Last updated
2007-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

femoral block, fascia iliaca block, ACL repair, post-operative analgesia, knee surgery, ACL damage, knee damage

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.

Interventions

PROCEDUREFemoral Block (with stimulating catheter)
PROCEDUREFemoral Block (without stimulating catheter)

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
pain relief; measured by WOMACbefore surgery and at days 7, 60, 90
pain relief; evaluated from standard datasheetover 48-hour period
pain relief; measured by VAS at rest and on activitybefore surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90

Secondary

MeasureTime frame
thigh circumference 20 cm above the kneemeasured before surgery and at days 7, 60, 90
neurological exam of femorocutaneous, femoral and obturator nervesevaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
level of activity; measured using questionnaireat 7-10 days and at 2 and 3 months
need for rescue analgesiain recovery room and at home
need for second bolus or crossing over between groups
knee range of bendingmeasured before surgery, and at days 7, 60, 90

Countries

Canada

Contacts

Primary ContactJuan F Asenjo, MD
jfasenjog@yahoo.com514-934-1934

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026