Arthroplasty, Replacement, KneeNCT02773537
Motor-Sparing Peripheral Nerve Blockade Facilitates Mobility Post Total Knee Arthroplasty: A Randomized Controlled Trial
A study testing Femoral nerve catheter and sciatic nerve block, Adductor canal catheter and selective tibial block and Adductor canal catheter only in people with Arthroplasty, Replacement, Knee, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Femoral nerve catheter and sciatic nerve block, Adductor canal catheter and selective tibial block and Adductor canal catheter only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Males and Females 18 years of age or older
- Undergoing elective primary total knee arthroplasty
- Patient is willing and able to give consent and participate
Who cannot join
- Inability to receive spinal anesthesia or peripheral nerve block
- Non-ambulatory patients
- Non- English speaking patients
- Vulnerable populations including prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty
The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).
Read the detailed description
Pain management for total knee replacement (TKR) patients has evolved rapidly over the previous decade. The most recent advances in anesthesia include peripheral nerve blockade, which offers the promise of earlier postoperative mobilization in addition to effective pain relief. The rapidity with which these advancements have been adopted seems to have outpaced the science to support them. The result has been the institution of countless combinations of perioperative pain management strategies in centers nationwide with little standardization, consistency, or objective evidence. The extent to which these various strategies achieve safe and effective perioperative pain control or functional preservation remains poorly defined. This prospective randomized control trial will aim to identify meaningful patient-centric outcome measures, differentiate from among three perioperative TKR anesthetic and analgesic strategies, and provide a template for interdisciplinary collaboration among orthopedic surgeons, anesthesiologists, physical therapists, and patients. With the knowledge gained further study will continue to refine the most optimal early pain control protocol.
All primary TKR patients undergoing surgery at the Medical University of South Carolina who are able to receive spinal anesthesia will be randomized prior to surgery to one of three forms of lower limb nerve blockade: 1) Continuous femoral nerve catheter plus single injection sciatic nerve block, 2) Adductor canal catheter plus selective tibial nerve block, 3) Adductor canal catheter alone. All patients will receive additional standardized pain medications as well as early mobilization with physical therapy. The primary outcome measure will be postoperative visual analog pain scale (VAS), with secondary measures to include validated patient-reported outcome measures, objective functional measures (timed-up-and-go (TUG), patient satisfaction scores, length of stay, discharge disposition, and complications. The investigators plan to enroll approximately 90 patients. This will allow us to reach our randomization goal of at least 75 patients while taking into account withdrawals. The 75 patients will be randomized into the three treatment three treatment arms over a 6-month recruitment period, with a 3 month follow-up for patient reported outcome and satisfaction data. A focus group will facilitate patient engagement and provide information for generation of a preference survey to guide future study design.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Femoral nerve catheter and sciatic nerve block, Adductor canal catheter and selective tibial block, Adductor canal catheter only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve catheter and sciatic nerve blockDrug
This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.
Adductor canal catheter and selective tibial blockDrug
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.
Adductor canal catheter onlyDrug
This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
| Study group | Role | What they receive |
|---|---|---|
| Randomization Group 1 | Active comparator | Femoral nerve catheter and sciatic nerve block Receives: Drug: Femoral nerve catheter and sciatic nerve block |
| Randomization Group 2 | Active comparator | Adductor canal catheter and selective tibial block Receives: Drug: Adductor canal catheter and selective tibial block |
| Randomization Group 3 | Active comparator | Adductor canal catheter only Receives: Drug: Adductor canal catheter only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Measurement Via VAS (Visual Analog Scale)
The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.
Measured: 48 hours after procedure
Secondary outcomes (7)
Narcotic Requirements
Narcotic dosages will be measured and reported as oral morphine milligram equivalents.
Measured: 48 hours after procedure
Functional Outcome Measures- Exstension/Knee Buckling
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. They will document the patient's ability to perform independent terminal knee extension and grade knee buckling with ambulation on a scale of 0-2 during each encounter. A grade of 0 indicates no knee buckling, 1 indicates slight buckling, and a grade of 2 represents knee buckling significant enough in the opinion of the physical therapist to require a knee immobilizer while ambulating. I higher score corresponds to a worse outcome. The numbers below in the outcome measure table are the number of patients who achieved terminal knee extension for had ANY knee buckling respectively.
Measured: 1-2 days after procedure
Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #1, the therapist will calculate the Activity Measure for Post-Acute Care (AM-PAC) score. The Activity Measure for Post Acute Care (AM-PAC) measures function in three domains: basic mobility, daily activities,and applied cognitive function. AM-PAC scores in each functional domain have a mean of 50 with a standard deviation of 10 and scores are distributed along a continuum of function. The AM-PAC tracks outcomes as a participant progresses across an episode of care with higher scores indicating an improved level of functioning.
Measured: Morning of post-op day 1 - 2 days after procedure
Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document distance walked by the patient.
Measured: Morning of post-op day 1 - 2 days after procedure
Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds
Functional outcome measures will be administered by members of the physical and occupational therapy team, who typically evaluate and treat patients once on the day of surgery and twice daily each day thereafter. On the morning of postoperative day #2, the therapist will document a timed up-and-go test (TUG).
Measured: Morning of post-op day 1 - 2 days after procedure
Patient Reported Pain and Function Outcomes
Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.
Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20 and the max is 100.
Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).
Measured: 6 Weeks after procedure
Patient Reported Pain and Function Outcomes
Short Form Health Survey (SF-12): 12 item abbreviated form of SF-36 survey that provides information about how participants feel, and how well they have been able to perform their usual activities. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning.
Patient Reported Outcome Measurement Information System (PROMIS): evaluates and monitors physical, mental, and social health. The minimum possible score is 20, the maximum is 100.
Knee injury and Osteoarthritis Outcome Score (KOOS)-Specifically Pain and Symptom Score: A Likert scale is used. All items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale (0=extreme; 100= none).
Measured: 3 Months after Procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacob Drew, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773537
- Sponsor's protocol ID
- Pro00042461
- Status last verified
- Mar 2019
- First submitted
- 3 May 2016
- Last updated
- 27 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparative Effectiveness Trial of Anesthesia/Analgesia Techniques for Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02773537
- Acronym / sponsor ID
- Pro00042461
- Conditions
- Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Posted 27 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this pilot study will be to develop a clinically meaningful, patient-centric, and pragmatic protocol to evaluate the comparative effectiveness of different strategies for achievement of the ideal balance between analgesia and functional mobility following total knee arthroplasty (TKA).
Detailed description
Pain management for total knee replacement (TKR) patients has evolved rapidly over the previous decade. The most recent advances in anesthesia include peripheral nerve blockade, which offers the promise of earlier postoperative mobilization in addition to effective pain relief. The rapidity with which these advancements have been adopted seems to have outpaced the science to support them. The result has been the institution of countless combinations of perioperative pain management strategies in centers nationwide with little standardization, consistency, or objective evidence. The extent to which these various strategies achieve safe and effective perioperative pain control or functional preservation remains poorly defined. This prospective randomized control trial will aim to identify meaningful patient-centric outcome measures, differentiate from among three perioperative TKR anesthetic and analgesic strategies, and provide a template for interdisciplinary collaboration among orthopedic surgeons, anesthesiologists, physical therapists, and patients. With the knowledge gained further study will continue to refine the most optimal early pain control protocol.
All primary TKR patients undergoing surgery at the Medical University of South Carolina who are able to receive spinal anesthesia will be randomized prior to surgery to one of three forms of lower limb nerve blockade: 1) Continuous femoral nerve catheter plus single injection sciatic nerve block, 2) Adductor canal catheter plus selective tibial nerve block, 3) Adductor canal catheter alone. All patients will receive additional standardized pain medications as well as early mobilization with physical therapy. The primary outcome measure will be postoperative visual analog pain scale (VAS), with secondary measures to include validated patient-reported outcome measures, objective functional measures (timed-up-and-go (TUG), patient satisfaction scores, length of stay, discharge disposition, and complications. The investigators plan to enroll approximately 90 patients. This will allow us to reach our randomization goal of at least 75 patients while taking into account withdrawals. The 75 patients will be randomized into the three treatment three treatment arms over a 6-month recruitment period, with a 3 month follow-up for patient reported outcome and satisfaction data. A focus group will facilitate patient engagement and provide information for generation of a preference survey to guide future study design.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomization Group 1 | Active comparator | Drug: Femoral nerve catheter and sciatic nerve blockFemoral nerve catheter and sciatic nerve block |
| Randomization Group 2 | Active comparator | Drug: Adductor canal catheter and selective tibial blockAdductor canal catheter and selective tibial block |
| Randomization Group 3 | Active comparator | Drug: Adductor canal catheter onlyAdductor canal catheter only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and Females 18 years of age or older
- Undergoing elective primary total knee arthroplasty
- Patient is willing and able to give consent and participate
Key exclusion criteria (4 listed)
- Inability to receive spinal anesthesia or peripheral nerve block
- Non-ambulatory patients
- Non- English speaking patients
- Vulnerable populations including prisoners
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 nerve catheter and sciatic nerve blockThis nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb. | Drug | Randomization Group 1 |
| Adductor canal catheter and selective tibial blockThis nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb. | Drug | Randomization Group 2 |
| Adductor canal catheter onlyThis nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb | Drug | Randomization Group 3 |
Primary outcome
Pain Measurement Via VAS (Visual Analog Scale)
Time frame: 48 hours after procedure
The primary outcome measure will be postoperative visual analog pain scale (VAS) score area under the curve (AUC) for 48 hours, recorded every six hours. Score Scale is 0 (no pain)- 10(most pain). A higher score corresponds to a worse outcome.
7 secondary outcomes
Narcotic Requirements
Time frame: 48 hours after procedure
Functional Outcome Measures- Exstension/Knee Buckling
Time frame: 1-2 days after procedure
Functional Outcome Measures- AMPAC (Activity Measure for Post-Acute Care)
Time frame: Morning of post-op day 1 - 2 days after procedure
Functional Outcome Measures- TUG (Timed Up and Go)- Distance Walked
Time frame: Morning of post-op day 1 - 2 days after procedure
Functional Outcome Measures- TUG (Timed Up and Go)- Time in Seconds
Time frame: Morning of post-op day 1 - 2 days after procedure
Patient Reported Pain and Function Outcomes
Time frame: 6 Weeks after procedure
Patient Reported Pain and Function Outcomes
Time frame: 3 Months after Procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jacob Drew, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral nerve catheter and sciatic nerve block, Adductor canal catheter and selective tibial block and Adductor canal catheter only in people with Arthroplasty, Replacement, Knee, run by Medical University of South Carolina 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 3 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 27 Mar 2019. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Measurement Via VAS (Visual Analog Scale) (time frame: 48 hours after procedure). 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 27 Mar 2019.