NCT00294073

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2006

Completed
Last Updated

June 19, 2007

Status Verified

August 1, 2005

First QC Date

February 17, 2006

Last Update Submit

June 18, 2007

Conditions

Pain, Postoperative

Keywords

femoral blockfascia iliaca blockACL repairpost-operative analgesiaknee surgeryACL damageknee damage

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Interventions

Fascia Iliaca BlockPROCEDURE
Femoral Block (with stimulating catheter)PROCEDURE
Femoral Block (without stimulating catheter)PROCEDURE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients coming for ACL or knee prosthesis surgery
  • Between 18-80 years old
  • Consenting for spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Related Publications (4)

  • 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.

    PMID: 12945024BACKGROUND

  • 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.

    PMID: 15138905BACKGROUND

  • 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.

    PMID: 15108988BACKGROUND

  • 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.

    PMID: 15103457BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Juan F Asenjo, MD

    Montreal General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan F Asenjo, MD

CONTACT

514-934-1934jfasenjog@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2006

First Posted

February 20, 2006

Study Start

July 1, 2005

Last Updated

June 19, 2007

Record last verified: 2005-08

Locations

CA(1)