Arthroplasty, Replacement, KneePhase 4NCT01345604
Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection After Total Knee Arthroplasty (TKA)
A Phase 4 study testing transcruciate injection of 20cc of normal saline and transcruciate injection of 20 cc of 0.5% Ropivacaine in people with Arthroplasty, Replacement, Knee, run by University of Saskatchewan at 1 site in Canada.
Trial summary
his study is being done because total knee replacements can leave patients with considerable pain after surgery. Therefore, many studies have been done to find the best ways to control knee pain after the surgery. Currently, a popular approach is to use many different techniques to control the pain. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- transcruciate injection of 20cc of normal saline and transcruciate injection of 20 cc of 0.5% Ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to May 2013
- Phase
- Phase 4
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists' (ASA) physical status classification (ASA) I and II patients undergoing unilateral total knee arthroplasty at Saskatoon City Hospital
- Patients recruited from the practice of 4 orthopedic surgeons
Who cannot join
- Inability to obtain informed consent
- Simultaneous bilateral total knee arthroplasty or revision cases
- Preexisting neurological deficits in the distribution of the femoral nerve or known diagnosis of peripheral neuropathy
- Coagulopathies
- Infection either systemically or at the needle insertion sites
- Allergies to local anesthetics or opioids
Show all 9Show fewer
- Patients with a history of narcotic dependency or chronic pain
- ASA III and IV
- Body Mass Index (BMI) > 40
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Posterior Knee Pain Following Total Knee Arthroplasty Using an Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection
his study is being done because total knee replacements can leave patients with considerable pain after surgery. Therefore, many studies have been done to find the best ways to control knee pain after the surgery. Currently, a popular approach is to use many different techniques to control the pain. This includes injecting freezing (local anesthetic) into the spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and using various kinds of medications (e.g. narcotics and anti-inflammatory medications). Studies have shown using this a combination of techniques can reduce pain and allow earlier discharge from the hospital. However, one downside to this approach is it does not usually control the pain in the back of the knee. One new technique has been used to try and overcome this. This technique is called a "posterior cruciate ligament block" or "PCL block". It involves injecting a drug into the back of the knee which will block the nerves in this area. Sometimes the investigators refer to this as "freezing".
The purpose of our study is to determine whether this "PCL Block" will improve pain after the total knee replacement surgery. The investigators will also determine whether this technique will improve movement in the knee and lessen narcotic usage after the surgery.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- transcruciate injection of 20cc of normal saline, transcruciate injection of 20 cc of 0.5% Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcruciate injection of 20cc of normal salineProcedure or surgery
Group 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
transcruciate injection of 20 cc of 0.5% RopivacaineProcedure or surgery
Group 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Procedure: transcruciate injection of 20cc of normal saline |
| Ropivicaine | Active comparator | Not described Receives: Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion
Measured: up to one week postoperative
Secondary outcomes (2)
Postoperative pain score
Pain scores will be recorded at rest and on attempt of achieving a 90 degree passive flexion of the knee.
Measured: in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm
Total narcotic consumption
Measured: up to 1 week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- Saskatoon Health Region
- Responsible party
- Principal investigator, Jacelyn Larson, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345604
- Sponsor's protocol ID
- PCL block
- Status last verified
- Nov 2016
- First submitted
- 28 Apr 2011
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Posterior Knee Pain Following Total Knee Arthroplasty Using an Intraoperative Posterior Cruciate Ligament (Transcruciate) Injection
- ClinicalTrials.gov ID
- NCT01345604
- Acronym / sponsor ID
- PCL block
- Conditions
- Arthroplasty, Replacement, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- Saskatoon Health Region
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 2 May 2011 (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.
his study is being done because total knee replacements can leave patients with considerable pain after surgery. Therefore, many studies have been done to find the best ways to control knee pain after the surgery. Currently, a popular approach is to use many different techniques to control the pain. This includes injecting freezing (local anesthetic) into the spinal column (spinal anesthetic), injecting freezing close to the nerves of the knee and using various kinds of medications (e.g. narcotics and anti-inflammatory medications). Studies have shown using this a combination of techniques can reduce pain and allow earlier discharge from the hospital. However, one downside to this approach is it does not usually control the pain in the back of the knee. One new technique has been used to try and overcome this. This technique is called a "posterior cruciate ligament block" or "PCL block". It involves injecting a drug into the back of the knee which will block the nerves in this area. Sometimes the investigators refer to this as "freezing".
The purpose of our study is to determine whether this "PCL Block" will improve pain after the total knee replacement surgery. The investigators will also determine whether this technique will improve movement in the knee and lessen narcotic usage after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Procedure: transcruciate injection of 20cc of normal saline |
| Ropivicaine | Active comparator | Procedure: transcruciate injection of 20 cc of 0.5% Ropivacaine |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists' (ASA) physical status classification (ASA) I and II patients undergoing unilateral total knee arthroplasty at Saskatoon City Hospital
- Patients recruited from the practice of 4 orthopedic surgeons
Key exclusion criteria (9 listed)
- Inability to obtain informed consent
- Simultaneous bilateral total knee arthroplasty or revision cases
- Preexisting neurological deficits in the distribution of the femoral nerve or known diagnosis of peripheral neuropathy
- Coagulopathies
- Infection either systemically or at the needle insertion sites
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 |
|---|---|---|
| transcruciate injection of 20cc of normal salineGroup 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively). | Procedure or surgery | Saline |
| transcruciate injection of 20 cc of 0.5% RopivacaineGroup 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively). | Procedure or surgery | Ropivicaine |
Primary outcome
Knee flexion
Time frame: up to one week postoperative
2 secondary outcomes
Postoperative pain score
Time frame: in PACU , on ward (baseline), and post-op day 1 & 2 at 10am & 6pm
Total narcotic consumption
Time frame: up to 1 week postoperative
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 15 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing transcruciate injection of 20cc of normal saline and transcruciate injection of 20 cc of 0.5% Ropivacaine in people with Arthroplasty, Replacement, Knee, run by University of Saskatchewan 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 2 inclusion and 9 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 15 Nov 2016. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Knee flexion (time frame: up to one week postoperative). 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 15 Nov 2016.