PainNCT01459861
Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
A study testing Canal Block and Capsular Injection and Femoral Nerve Block with Tibial Nerve Block in people with Pain and Osteoarthritis, run by Trinity Health Of New England at 1 site in United States.
Trial summary
The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Canal Block and Capsular Injection and Femoral Nerve Block with Tibial Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Sep 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- knee arthroplasty
- ages 18-80
Who cannot join
- history of neurological disease
- diabetes
- pregnancy
- neuropathy
- chronic narcotic use
- allergy to local anesthetic solution or NSAIDS
- inability to give consent or cooperate with the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement
The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Canal Block and Capsular Injection, Femoral Nerve Block with Tibial Nerve Block
- Keywords
- early ambulation, knee arthroplasty
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canal Block and Capsular InjectionProcedure or surgery
Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.
Femoral Nerve Block with Tibial Nerve BlockProcedure or surgery
Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.
| Study group | Role | What they receive |
|---|---|---|
| Canal Block and Capsular Injection | Experimental | Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution. Receives: Procedure: Canal Block and Capsular Injection |
| Femoral with Tibial Nerve Block | Active comparator | Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa. Receives: Procedure: Femoral Nerve Block with Tibial Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to ambulate post operatively.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
Measured: Up to 3 days (72 hours) post surgery.
Secondary outcomes (2)
Pain scores at rest and with knee flexion.
Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room.
Measured: Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Amount of opioid consumption post surgery for 72 hours.
Measured: Up to 3 days (72 hours) post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionSep 2012
Why it stopped: Administratively closed early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjay Sinha, M.D., Principal investigator, WVU Medicine Thomas Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459861
- Sponsor's protocol ID
- 11-09-003
- Status last verified
- Feb 2013
- First submitted
- 6 Oct 2011
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement
- ClinicalTrials.gov ID
- NCT01459861
- Acronym / sponsor ID
- 11-09-003
- Conditions
- Pain, Osteoarthritis
- Keywords
- early ambulation, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively closed early
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Oct 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.
The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canal Block and Capsular Injection | Experimental | Procedure: Canal Block and Capsular InjectionAdductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution. |
| Femoral with Tibial Nerve Block | Active comparator | Procedure: Femoral Nerve Block with Tibial Nerve BlockContinuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- knee arthroplasty
- ages 18-80
Key exclusion criteria (7 listed)
- history of neurological disease
- diabetes
- pregnancy
- neuropathy
- chronic narcotic use
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 |
|---|---|---|
| Canal Block and Capsular InjectionContinuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000. | Procedure or surgery | Canal Block and Capsular Injection |
| Femoral Nerve Block with Tibial Nerve BlockContinuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml. | Procedure or surgery | Femoral with Tibial Nerve Block |
Primary outcome
Ability to ambulate post operatively.
Time frame: Up to 3 days (72 hours) post surgery.
Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.
2 secondary outcomes
Pain scores at rest and with knee flexion.
Time frame: Up to 3 days ( 72 hours) after surgery
Pain Medication Consumption
Time frame: Up to 3 days (72 hours) post surgery
Results and safety
The study was stopped early (reason given: Administratively closed early). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
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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.
Sanjay Sinha, M.D. principal investigator
WVU Medicine Thomas Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Canal Block and Capsular Injection and Femoral Nerve Block with Tibial Nerve Block in people with Pain and Osteoarthritis, run by Trinity Health Of New England at 1 site in United States.
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 7 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: stopped early, as of the sponsor's last update on 6 Mar 2013. 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 United States. 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 was stopped early (reason given: Administratively closed early). Results are not available in the source record.
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?
Ability to ambulate post operatively. (time frame: Up to 3 days (72 hours) post 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 6 Mar 2013.