Total Knee ArthroplastyNCT00726219
Insertion Distance of Femoral Perineural Catheters in the Context of Major Knee Surgery.
A study testing Femoral perineural catheter in people with Total Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites in Canada.
Trial summary
This study is designed to compare femoral perineural catheter insertion distances, in order to help determine which is the best for pain relief after knee surgery. Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is inserted deeper (7cm compared to 3 cm) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Femoral perineural catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older undergoing major knee surgery.
Who cannot join
- Coagulopathy
- Pregnancy
- Allergy to local anesthetics
- Patient unable to consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CSSS Chicoutimi
Chicoutimi, Quebec, G7H 5H6
Centre Hospitalier de l'Université de Montréal (Hôpital Notre-Dame)
Montreal, Quebec, H2L 4M1
About this study
Official title: Influence of the Insertion Distance on Loss of Sensation Produced by Femoral Perineural Catheters in the Context of Major Knee Surgery.
This study is designed to compare femoral perineural catheter insertion distances, in order to help determine which is the best for pain relief after knee surgery.
Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is inserted deeper (7cm compared to 3 cm)
Read the detailed description
Pain after knee surgery is reported as severe for 60% of patients, and is a major concern in both hospitalised and ambulatory surgery patients. Pain control is particularly important, as adequate analgesia allows rapid mobilisation of the operated knee and prevents complications related to immobility. Several methods have been proposed to treat this pain, the most promising being injection of local anesthetic close to the femoral nerve. The injection of local anesthetics around the femoral nerve reduces sensation from the knee and provides better pain relief after surgery than narcotic medication. To prolong the duration of the analgesia, a small catheter must be positioned next to the nerve. Through this catheter, small quantities of local anesthetics can be continuously delivered for several hours after surgery, effectively relieving the worst of the pain.
To date, the administration of local anesthetics through a catheter next to the femoral nerve has been shown to improve pain relief after knee replacement surgery. These pain relief benefits have resulted in faster recovery after total knee replacement. Until recently, catheter techniques were not frequently used due to technical difficulties encountered when attempting to find the femoral nerve, as well as difficulties related to catheter displacement after surgery. Due to recent improvements in nerve and catheter localisation, catheter installation has become easier, more precise and more reliable. However, the distance at which the catheter must be advanced next to the femoral nerve in order to provide the best pain relief remains unknown. Insertion distance could influence the initial quality and distribution of the freezing, its duration, or both. Therefore, this study is designed to compare two catheter insertion distances, in order to help determine which is best for pain relief after knee surgery.
Patients will be randomly assigned to the following groups:
- Group 1: 3 cm insertion
- Group 2: 7 cm insertion
The anesthesiologist will insert a catheter close to the femoral nerve, at the junction of the thigh and torso immediately before beginning of anesthesia for surgery. The usual medication will be used to make installation more comfortable. The exact location where the catheter will be put into place will be identified using an ultrasound machine. This device will allow the anesthesiologist to identify the various anatomical structures. A specially designed needle will be inserted next to the femoral nerve, and its position will be confirmed with a neurostimulator. Once the adequacy of needle position is confirmed, the anesthesiologist will introduce 3 cm(Group 1) or 7 cm (Group 2)of the catheter through the needle, and then will withdraw the needle. The catheter will be fixed in place to avoid displacement.
Patients will receive standard regional or general anesthesia for this type of surgery.
After surgery, pain will be assessed using a verbal numeric pain scale. A Patient Controlled Analgesia pump will be provided to the patients. In addition, all patients will receive local anesthetics through their femoral catheter for at least 24 hours after surgery, which will partially freeze the knee.
Patients will be asked to fill out a pain intensity measurement form using a 0-10 pain scale at 3, 6 and 24 hours after surgery.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Femoral perineural catheter
- Keywords
- Major, knee, surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral perineural catheterOther
Comparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Insertion distance of femoral catheter: 3cm Receives: Other: Femoral perineural catheter |
| 2 | Other | Insertion distance of femoral catheter: 7cm Receives: Other: Femoral perineural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensory block assessment
Measured: 24 hours after surgery
Secondary outcomes (1)
Quality of pain relief
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Stephan R Williams, MD, PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726219
- Sponsor's protocol ID
- HD07.052
- Status last verified
- Jun 2010
- First submitted
- 29 Jul 2008
- Last updated
- 10 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Insertion Distance on Loss of Sensation Produced by Femoral Perineural Catheters in the Context of Major Knee Surgery.
- ClinicalTrials.gov ID
- NCT00726219
- Acronym / sponsor ID
- HD07.052
- Conditions
- Total Knee Arthroplasty
- Keywords
- Major, knee, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 Jul 2008 (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.
This study is designed to compare femoral perineural catheter insertion distances, in order to help determine which is the best for pain relief after knee surgery.
Hypothesis: the quality of the femoral nerve block will not be inferior if the catheter is inserted deeper (7cm compared to 3 cm)
Detailed description
Pain after knee surgery is reported as severe for 60% of patients, and is a major concern in both hospitalised and ambulatory surgery patients. Pain control is particularly important, as adequate analgesia allows rapid mobilisation of the operated knee and prevents complications related to immobility. Several methods have been proposed to treat this pain, the most promising being injection of local anesthetic close to the femoral nerve. The injection of local anesthetics around the femoral nerve reduces sensation from the knee and provides better pain relief after surgery than narcotic medication. To prolong the duration of the analgesia, a small catheter must be positioned next to the nerve. Through this catheter, small quantities of local anesthetics can be continuously delivered for several hours after surgery, effectively relieving the worst of the pain.
To date, the administration of local anesthetics through a catheter next to the femoral nerve has been shown to improve pain relief after knee replacement surgery. These pain relief benefits have resulted in faster recovery after total knee replacement. Until recently, catheter techniques were not frequently used due to technical difficulties encountered when attempting to find the femoral nerve, as well as difficulties related to catheter displacement after surgery. Due to recent improvements in nerve and catheter localisation, catheter installation has become easier, more precise and more reliable. However, the distance at which the catheter must be advanced next to the femoral nerve in order to provide the best pain relief remains unknown. Insertion distance could influence the initial quality and distribution of the freezing, its duration, or both. Therefore, this study is designed to compare two catheter insertion distances, in order to help determine which is best for pain relief after knee surgery.
Patients will be randomly assigned to the following groups:
- Group 1: 3 cm insertion
- Group 2: 7 cm insertion
The anesthesiologist will insert a catheter close to the femoral nerve, at the junction of the thigh and torso immediately before beginning of anesthesia for surgery. The usual medication will be used to make installation more comfortable. The exact location where the catheter will be put into place will be identified using an ultrasound machine. This device will allow the anesthesiologist to identify the various anatomical structures. A specially designed needle will be inserted next to the femoral nerve, and its position will be confirmed with a neurostimulator. Once the adequacy of needle position is confirmed, the anesthesiologist will introduce 3 cm(Group 1) or 7 cm (Group 2)of the catheter through the needle, and then will withdraw the needle. The catheter will be fixed in place to avoid displacement.
Patients will receive standard regional or general anesthesia for this type of surgery.
After surgery, pain will be assessed using a verbal numeric pain scale. A Patient Controlled Analgesia pump will be provided to the patients. In addition, all patients will receive local anesthetics through their femoral catheter for at least 24 hours after surgery, which will partially freeze the knee.
Patients will be asked to fill out a pain intensity measurement form using a 0-10 pain scale at 3, 6 and 24 hours after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Femoral perineural catheterInsertion distance of femoral catheter: 3cm |
| 2 | Other | Other: Femoral perineural catheterInsertion distance of femoral catheter: 7cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years or older undergoing major knee surgery.
Key exclusion criteria (4 listed)
- Coagulopathy
- Pregnancy
- Allergy to local anesthetics
- Patient unable to consent
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 |
|---|---|---|
| Femoral perineural catheterComparison of 2 insertion distances (3 vs 7 cm) for a femoral perineural catheter in the context of major knee surgery. | Other | 1, 2 |
Primary outcome
Sensory block assessment
Time frame: 24 hours after surgery
1 secondary outcome
Quality of pain relief
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2011.
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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.
Stephan R Williams, MD, PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral perineural catheter in people with Total Knee Arthroplasty, run by Centre hospitalier de l'Université de Montréal (CHUM) at 2 sites 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensory block assessment (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2011.