PainPhase 4NCT03182933
Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
A Phase 4 study testing Peripheral Nerve Blockade, 10 meter walk test on post-operative day 1 and In person and over the phone questionnaire in people with Pain, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain
- What is being tested?
- Peripheral Nerve Blockade, 10 meter walk test on post-operative day 1 and In person and over the phone questionnaire
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2017to 16 Jul 2018
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject is scheduled for elective unilateral TKA;
- The subject is ≥ 18 years and ≤ 80 years;
- The subject's weight is between 65-130 kg;
- The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
- The patient agrees to receive an adductor canal block;
- American Society of Anesthesiologists class 1-3.
Who cannot join
- Subject is < 18 years of age or >80 years of age;
- Subject is non-English speaking;
- Subject is known or believed to be pregnant;
- Subject is a prisoner;
- Subject has impaired decision-making capacity per discretion of the Investigator;
- Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
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- Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
- Significant pre-existing neuropathy on the operative limb;
- Significant renal, cardiac or hepatic disease per discretion of the investigator;
- American Society of Anesthesiologists class 4-5;
- Known hypersensitivity and/or allergies to local anesthetics;
- Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.
Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.
Read the detailed description
Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.
- Conditions
- Pain
- Being tested
- Peripheral Nerve Blockade, 10 meter walk test on post-operative day 1, In person and over the phone questionnaire, Force transduction of quadriceps strength
- Keywords
- 10 meter walk test, Opioid consumption
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve BlockadeDrug
Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
10 meter walk test on post-operative day 1Behavioural
Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
In person and over the phone questionnaireOther
Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
Force transduction of quadriceps strengthDevice
Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine group | Experimental | 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) Receives: Drug: Peripheral Nerve Blockade; Behavioral: 10 meter walk test on post-operative day 1; Other: In person and over the phone questionnaire; Device: Force transduction of quadriceps strength |
| Standard bupivacaine group | Active comparator | 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) Receives: Drug: Peripheral Nerve Blockade; Behavioral: 10 meter walk test on post-operative day 1; Other: In person and over the phone questionnaire; Device: Force transduction of quadriceps strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Meter Walk Test
Time to comfortably walk 10 meters as deemed safe by physical therapy
Measured: 24 hours
Secondary outcomes (4)
Pain Scores
Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.
Measured: Day 0, Day 1, Day 2, Day 3
Opioid Consumption in Morphine Equivalents
Total opioid consumption will be measured in all patients over the course of 3 days and converted to oral morphine equivalents so that it can be statistically compared.
Measured: Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3
Number of Participants Who Experienced Nausea
Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview
Measured: Day 0, Day 1, Day 2, Day 3
Quadriceps Strength
Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start30 May 2017
- Primary completion16 Jul 2018
- Study completion16 Jul 2018
Why it stopped: Terminated due to surgeon preferences
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 PainStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182933
- Sponsor's protocol ID
- 2016-0869
- Status last verified
- Jun 2019
- First submitted
- 1 Jun 2017
- Last updated
- 25 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT03182933
- Acronym / sponsor ID
- 2016-0869
- Conditions
- Pain
- Keywords
- 10 meter walk test, Opioid consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to surgeon preferences
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 16 Jul 2018 (actual)
- Study completion
- 16 Jul 2018 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 25 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.
Detailed description
Total knee arthroplasty (TKA) can be associated with a large amount of postoperative pain. This pain can oftentimes be severe enough to limit participation in physical therapy and ultimately delay discharge resulting in increased cost. Several strategies have been developed in an effort to decrease postoperative pain following TKA while maintaining lower extremity strength and maximizing participation in physical therapy. Recently, adductor canal blockade has gained popularity as it is reported to provide analgesia to the anterior knee without resulting in significant quadriceps muscle weakness. One downside of single shot peripheral blockade is the duration of analgesia can oftentimes be short lived. The advent of depot local anesthetics has made this an attractive option, especially in busy practices where placing peri-neural catheters may not be practical or cost effective. This study aims to carefully evaluate this relationship using a physical therapy evaluation method that relies on both motor strength and pain control. In addition, we hope to carefully evaluate motor strength using a novel method of strength measurement in an effort to further evaluate the impact of depot local anesthetic injection into the adductor canal on physical therapy and analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine group | Experimental | Drug: Peripheral Nerve Blockade, Behavioral: 10 meter walk test on post-operative day 1, Other: In person and over the phone questionnaire, Device: Force transduction of quadriceps strength20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) |
| Standard bupivacaine group | Active comparator | Drug: Peripheral Nerve Blockade, Behavioral: 10 meter walk test on post-operative day 1, Other: In person and over the phone questionnaire, Device: Force transduction of quadriceps strength20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is scheduled for elective unilateral TKA;
- The subject is ≥ 18 years and ≤ 80 years;
- The subject's weight is between 65-130 kg;
- The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
- The patient agrees to receive an adductor canal block;
Key exclusion criteria (12 listed)
- Subject is < 18 years of age or >80 years of age;
- Subject is non-English speaking;
- Subject is known or believed to be pregnant;
- Subject is a prisoner;
- Subject has impaired decision-making capacity per discretion of the Investigator;
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 |
|---|---|---|
| Peripheral Nerve BlockadeEach study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization | Drug | Liposomal bupivacaine group, Standard bupivacaine group |
| 10 meter walk test on post-operative day 1Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist | Behavioural | Liposomal bupivacaine group, Standard bupivacaine group |
| In person and over the phone questionnairePresuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores | Other | Liposomal bupivacaine group, Standard bupivacaine group |
| Force transduction of quadriceps strengthPatient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1 | Device | Liposomal bupivacaine group, Standard bupivacaine group |
Primary outcome
10 Meter Walk Test
Time frame: 24 hours
Time to comfortably walk 10 meters as deemed safe by physical therapy
4 secondary outcomes
Pain Scores
Time frame: Day 0, Day 1, Day 2, Day 3
Opioid Consumption in Morphine Equivalents
Time frame: Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3
Number of Participants Who Experienced Nausea
Time frame: Day 0, Day 1, Day 2, Day 3
Quadriceps Strength
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 Peripheral Nerve Blockade, 10 meter walk test on post-operative day 1 and In person and over the phone questionnaire in people with Pain, run by University of Wisconsin, Madison 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 6 inclusion and 12 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 25 Jun 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.
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?
Yes. Results are posted in the registry (first posted 25 Jun 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?
10 Meter Walk Test (time frame: 24 hours). 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 25 Jun 2019.