Pain, PostoperativePhase 3NCT00294073
Defining the Best Approach to Block the Pain After Knee Surgery
A Phase 3 study testing Fascia Iliaca Block, Femoral Block (with stimulating catheter) and Femoral Block (without stimulating catheter) in people with Pain, Postoperative, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Fascia Iliaca Block, Femoral Block (with stimulating catheter) and Femoral Block (without stimulating catheter)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2005to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients coming for ACL or knee prosthesis surgery
- Between 18-80 years old
- Consenting for spinal anesthesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Juan F Asenjo, MD
About this study
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Fascia Iliaca Block, Femoral Block (with stimulating catheter), Femoral Block (without stimulating catheter)
- Keywords
- femoral block, fascia iliaca block, ACL repair, post-operative analgesia, knee surgery, ACL damage, knee damage
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia Iliaca BlockProcedure or surgery
Femoral Block (with stimulating catheter)Procedure or surgery
Femoral Block (without stimulating catheter)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
pain relief; measured by VAS at rest and on activity
Measured: before surgery, before discharge from PACU and on evenings of days 1, 2, 7, 60, 90
pain relief; measured by WOMAC
Measured: before surgery and at days 7, 60, 90
pain relief; evaluated from standard datasheet
Measured: over 48-hour period
Secondary outcomes (6)
knee range of bending
Measured: measured before surgery, and at days 7, 60, 90
thigh circumference 20 cm above the knee
Measured: measured before surgery and at days 7, 60, 90
neurological exam of femorocutaneous, femoral and obturator nerves
Measured: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
level of activity; measured using questionnaire
Measured: at 7-10 days and at 2 and 3 months
need for rescue analgesia
Measured: in recovery room and at home
need for second bolus or crossing over between groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Juan F Asenjo, MD, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294073
- Sponsor's protocol ID
- GEN#05-002
- Other IDs
- REC#02-030
- Status last verified
- Aug 2005
- First submitted
- 17 Feb 2006
- Last updated
- 19 Jun 2007
- Results posted
- No
Publications
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.
PubMed 12945024Salinas 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.
PubMed 15138905Williams 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.
PubMed 15108988Eriksson 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.
PubMed 15103457
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Best Approach to Block the Pain After Knee Surgery
- ClinicalTrials.gov ID
- NCT00294073
- Acronym / sponsor ID
- GEN#05-002
- Conditions
- Pain, Postoperative
- Keywords
- femoral block, fascia iliaca block, ACL repair, post-operative analgesia, knee surgery, ACL damage, knee damage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jul 2005
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients coming for ACL or knee prosthesis surgery
- Between 18-80 years old
- Consenting for spinal anesthesia
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia Iliaca Block | Procedure or surgery | – |
| Femoral Block (with stimulating catheter) | Procedure or surgery | – |
| Femoral Block (without stimulating catheter) | Procedure or surgery | – |
Primary outcome
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
pain relief; measured by WOMAC
Time frame: before surgery and at days 7, 60, 90
pain relief; evaluated from standard datasheet
Time frame: over 48-hour period
6 secondary outcomes
knee range of bending
Time frame: measured before surgery, and at days 7, 60, 90
thigh circumference 20 cm above the knee
Time frame: measured before surgery and at days 7, 60, 90
neurological exam of femorocutaneous, femoral and obturator nerves
Time frame: evaluated once spinal anesthesia has worn off, post-surgery, before anesthesia
level of activity; measured using questionnaire
Time frame: at 7-10 days and at 2 and 3 months
need for rescue analgesia
Time frame: in recovery room and at home
need for second bolus or crossing over between groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2007.
- Background: PubMed 12945024Morau 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.
- Background: PubMed 15138905Salinas 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.
- Background: PubMed 15108988Williams 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.
- Background: PubMed 15103457Eriksson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Asenjo, MD principal investigator
Montreal General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fascia Iliaca Block, Femoral Block (with stimulating catheter) and Femoral Block (without stimulating catheter) in people with Pain, Postoperative, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan F Asenjo, MD (514-934-1934 ext. 43261, jfasenjog@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294073, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2007.