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Defining the Best Approach to Block the Pain After Knee Surgery

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Fascia Iliaca Block
Femoral Block (with stimulating catheter)
Femoral Block (without stimulating catheter)
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring femoral block, fascia iliaca block, ACL repair, post-operative analgesia, knee surgery, ACL damage, knee damage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montreal General HospitalRecruiting

Outcomes

Primary Outcome Measures

pain relief; measured by VAS at rest and on activity
pain relief; measured by WOMAC
pain relief; evaluated from standard datasheet

Secondary Outcome Measures

knee range of bending
thigh circumference 20 cm above the knee
neurological exam of femorocutaneous, femoral and obturator nerves
level of activity; measured using questionnaire
need for rescue analgesia
need for second bolus or crossing over between groups

Full Information

First Posted
February 17, 2006
Last Updated
June 18, 2007
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00294073
Brief Title
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

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
femoral block, fascia iliaca block, ACL repair, post-operative analgesia, knee surgery, ACL damage, knee damage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Fascia Iliaca Block
Intervention Type
Procedure
Intervention Name(s)
Femoral Block (with stimulating catheter)
Intervention Type
Procedure
Intervention Name(s)
Femoral Block (without stimulating catheter)
Primary Outcome Measure Information:
Title
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
Title
pain relief; measured by WOMAC
Time Frame
before surgery and at days 7, 60, 90
Title
pain relief; evaluated from standard datasheet
Time Frame
over 48-hour period
Secondary Outcome Measure Information:
Title
knee range of bending
Time Frame
measured before surgery, and at days 7, 60, 90
Title
thigh circumference 20 cm above the knee
Time Frame
measured before surgery and at days 7, 60, 90
Title
neurological exam of femorocutaneous, femoral and obturator nerves
Time Frame
evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
Title
level of activity; measured using questionnaire
Time Frame
at 7-10 days and at 2 and 3 months
Title
need for rescue analgesia
Time Frame
in recovery room and at home
Title
need for second bolus or crossing over between groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juan F Asenjo, MD
Phone
514-934-1934
Ext
43261
Email
jfasenjog@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan F Asenjo, MD
Organizational Affiliation
Montreal General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan F Asenjo, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
12945024
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.
Results Reference
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PubMed Identifier
15138905
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.
Results Reference
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PubMed Identifier
15108988
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.
Results Reference
background
PubMed Identifier
15103457
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.
Results Reference
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Defining the Best Approach to Block the Pain After Knee Surgery

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