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Terminated due to surgeon preferences
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Study will evaluate the effect of liposomal bupivacaine versus standard bupivacaine on physical therapy measures and pain scores as well as opiate consumption.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine group | Experimental | 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) |
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| Standard bupivacaine group | Active Comparator | 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral Nerve Blockade | Drug | Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 10 Meter Walk Test | Time to comfortably walk 10 meters as deemed safe by physical therapy | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores | Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The American Center | Madison | Wisconsin | 53718 | United States |
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Study aimed to obtain 70 patients to account for dropout, however was sufficiently powered if 60 patients enrolled. Study was terminated after 64th patient due to surgeon preferences.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine Group | 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 7, 2017 |
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| 10 meter walk test on post-operative day 1 | Behavioral | Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist |
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| In person and over the phone questionnaire | Other | 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 |
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| Force transduction of quadriceps strength | Device | 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 |
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| 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 | 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. | 24 hours |
| FG001 | Standard Bupivacaine Group | 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine Group | 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 |
| BG001 | Standard Bupivacaine Group | 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 10 Meter Walk Test | Time to comfortably walk 10 meters as deemed safe by physical therapy | Posted | Mean | Standard Deviation | seconds | 24 hours |
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| Secondary | Pain Scores | Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain. | Posted | Mean | Standard Deviation | score on a scale | Day 0, Day 1, Day 2, Day 3 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Morphine equivalents | Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3 |
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| Secondary | Number of Participants Who Experienced Nausea | Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview | Posted | Count of Participants | Participants | No | Day 0, Day 1, Day 2, Day 3 |
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| Secondary | Quadriceps Strength | Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected. | Posted | Mean | Standard Deviation | Pounds of Force | 24 hours |
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Up to 72 hours
Any events that were deemed to be reportable events were discussed with the IRB
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine Group | 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 | 0 | 31 | 0 | 31 | 1 | 31 |
| EG001 | Standard Bupivacaine Group | 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: 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 1: 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 questionnaire: 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 strength: 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 | 0 | 32 | 0 | 32 | 0 | 32 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Falls | Musculoskeletal and connective tissue disorders | Fall | Systematic Assessment | Fall as a result of prolonged quadriceps weakness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Zitur - research program manager | University of Wisconsin | 6082638118 | lzitur@wisc.edu |
| May 7, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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