Total Knee ArthroplastyNCT02495805
Ultrasound-guided Continuous Proximal Adductor Canal vs Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
A study testing Continuous proximal adductor canal block and Continuous femoral nerve block in people with Total Knee Arthroplasty, run by Yale University.
Trial summary
The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Continuous proximal adductor canal block and Continuous femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Nov 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
- The patient will need to be able to have decision-making capacity and ability to consent for the study.
Who cannot join
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
- Patients unable to have decision-making capacity and ability to consent for the study.
About this study
Official title: Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.
Read the detailed description
Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
- Conditions
- Total Knee Arthroplasty
- Being tested
- Continuous proximal adductor canal block, Continuous femoral nerve block
- Keywords
- a continuous proximal adductor canal block (ACB), continuous femoral nerve block (FNB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous proximal adductor canal blockProcedure or surgery
Also called ACB
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Continuous femoral nerve blockProcedure or surgery
Also called FNB
Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block (ACB) | Active comparator | Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery. Receives: Procedure: Continuous proximal adductor canal block |
| femoral nerve block (FNB) | Active comparator | Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery. Receives: Procedure: Continuous femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor effects
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Measured: 24 hours (postoperatively)
Secondary outcomes (5)
Pain score
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Measured: On average between 6 and 8 hours postoperatively
Pain score
Subjects' pain will be assessed using a numerical pain score, where 10 is the greatest amount of pain.
Measured: 24 hours (postoperatively)
Opioid consumption
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Measured: On average between 6 and 8 hours postoperatively
Opioid consumption
Subjects' pain will be assessed by tracking opioid consumption postoperatively.
Measured: 24 hours (postoperatively)
Motor effects
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
Measured: On average between 6 and 8 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Study never officially began- currently closed with IRB.
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 Yale UniversityThe 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
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richa Wardham, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495805
- Sponsor's protocol ID
- 1508016335
- Status last verified
- Dec 2016
- First submitted
- 30 Jun 2015
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Continuous Proximal Adductor Canal Versus Continuous Femoral Nerve Block for Postoperative Pain Control and Rehabilitation Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02495805
- Acronym / sponsor ID
- 1508016335
- Conditions
- Total Knee Arthroplasty
- Keywords
- a continuous proximal adductor canal block (ACB), continuous femoral nerve block (FNB)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never officially began- currently closed with IRB.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Jul 2015 (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 the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.
Detailed description
Patients meeting the criteria: American Society of Anesthesiologists (ASA) class I and II, that are scheduled for elective total knee arthroplasty, will be recruited into the study. Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block (ACB) | Active comparator | Procedure: Continuous proximal adductor canal blockSubjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery. |
| femoral nerve block (FNB) | Active comparator | Procedure: Continuous femoral nerve blockSubjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
- The patient will need to be able to have decision-making capacity and ability to consent for the study.
Key exclusion criteria (2 listed)
- Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
- Patients unable to have decision-making capacity and ability to consent for the study.
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 |
|---|---|---|
| Continuous proximal adductor canal blockAlso: ACBSubjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB). | Procedure or surgery | adductor canal block (ACB) |
| Continuous femoral nerve blockAlso: FNBSubjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB). | Procedure or surgery | femoral nerve block (FNB) |
Primary outcome
Motor effects
Time frame: 24 hours (postoperatively)
Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.
5 secondary outcomes
Pain score
Time frame: On average between 6 and 8 hours postoperatively
Pain score
Time frame: 24 hours (postoperatively)
Opioid consumption
Time frame: On average between 6 and 8 hours postoperatively
Opioid consumption
Time frame: 24 hours (postoperatively)
Motor effects
Time frame: On average between 6 and 8 hours postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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.
Richa Wardham, MD principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A study testing Continuous proximal adductor canal block and Continuous femoral nerve block in people with Total Knee Arthroplasty, run by Yale University.
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 2 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: withdrawn, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Motor effects (time frame: 24 hours (postoperatively)). 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 9 Dec 2016.