Pain
Conditions
Keywords
10 meter walk test, Opioid consumption
Brief summary
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.
Interventions
Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
BEHAVIORAL10 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
OTHERIn 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
DEVICEForce 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
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is scheduled for elective unilateral TKA; 2. The subject is ≥ 18 years and ≤ 80 years; 3. The subject's weight is between 65-130 kg; 4. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural); 5. The patient agrees to receive an adductor canal block; 6. American Society of Anesthesiologists class 1-3.
Exclusion criteria
1. Subject is \< 18 years of age or \>80 years of age; 2. Subject is non-English speaking; 3. Subject is known or believed to be pregnant; 4. Subject is a prisoner; 5. Subject has impaired decision-making capacity per discretion of the Investigator; 6. Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration; 7. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate; 8. Significant pre-existing neuropathy on the operative limb; 9. Significant renal, cardiac or hepatic disease per discretion of the investigator; 10. American Society of Anesthesiologists class 4-5; 11. Known hypersensitivity and/or allergies to local anesthetics; 12. Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 10 Meter Walk Test | 24 hours | Time to comfortably walk 10 meters as deemed safe by physical therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | Day 0, Day 1, Day 2, Day 3 | Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain. |
| Opioid Consumption in Morphine Equivalents | Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3 | 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. |
| Number of Participants Who Experienced Nausea | Day 0, Day 1, Day 2, Day 3 | Post operative nausea and vomiting as documented in the PACU and volunteered in an over the phone interview |
| Quadriceps Strength | 24 hours | Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 31 |
| 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 | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Standard Bupivacaine Group | Total | Liposomal Bupivacaine Group |
|---|---|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 6.9 | 65.8 years STANDARD_DEVIATION 12.9 | 66.6 years STANDARD_DEVIATION 9.5 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 32 participants | 63 participants | 31 participants |
| Sex: Female, Male Female | 21 Participants | 46 Participants | 25 Participants |
| Sex: Female, Male Male | 11 Participants | 17 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 1 / 31 | 0 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
10 Meter Walk Test
Time to comfortably walk 10 meters as deemed safe by physical therapy
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine Group | 10 Meter Walk Test | 17.1 seconds | Standard Deviation 8.9 |
| Standard Bupivacaine Group | 10 Meter Walk Test | 13.4 seconds | Standard Deviation 5.2 |
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
Time frame: Day 0, Day 1, Day 2, Day 3
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Liposomal Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 0 (PACU) | 1 Participants |
| Liposomal Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 1 | 12 Participants |
| Liposomal Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 2 | 3 Participants |
| Liposomal Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 3 | 4 Participants |
| Standard Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 3 | 6 Participants |
| Standard Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 0 (PACU) | 0 Participants |
| Standard Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 2 | 6 Participants |
| Standard Bupivacaine Group | Number of Participants Who Experienced Nausea | Day 1 | 11 Participants |
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.
Time frame: Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 0 (PACU) | 7.1 Morphine equivalents | Standard Deviation 8.4 |
| Liposomal Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 2 | 39.5 Morphine equivalents | Standard Deviation 28.6 |
| Liposomal Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 1 | 51.2 Morphine equivalents | Standard Deviation 29.2 |
| Liposomal Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 3 | 25.8 Morphine equivalents | Standard Deviation 33 |
| Liposomal Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 0 (OR) | 2.3 Morphine equivalents | Standard Deviation 6.9 |
| Standard Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 3 | 28.2 Morphine equivalents | Standard Deviation 20.4 |
| Standard Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 0 (OR) | 0.5 Morphine equivalents | Standard Deviation 2.7 |
| Standard Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 0 (PACU) | 5.9 Morphine equivalents | Standard Deviation 11.4 |
| Standard Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 1 | 66.1 Morphine equivalents | Standard Deviation 36 |
| Standard Bupivacaine Group | Opioid Consumption in Morphine Equivalents | Day 2 | 54.8 Morphine equivalents | Standard Deviation 37.9 |
Secondary
Pain Scores
Visual Analog Scores on a scale of 1-10, where 1 is pain free and 10 is the most pain.
Time frame: Day 0, Day 1, Day 2, Day 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Bupivacaine Group | Pain Scores | Day 0 | 4.9 score on a scale | Standard Deviation 2.4 |
| Liposomal Bupivacaine Group | Pain Scores | Day 1 | 4.1 score on a scale | Standard Deviation 2.3 |
| Liposomal Bupivacaine Group | Pain Scores | Day 2 | 4.4 score on a scale | Standard Deviation 2 |
| Liposomal Bupivacaine Group | Pain Scores | Day 3 | 4.5 score on a scale | Standard Deviation 2.2 |
| Standard Bupivacaine Group | Pain Scores | Day 3 | 5 score on a scale | Standard Deviation 2.3 |
| Standard Bupivacaine Group | Pain Scores | Day 0 | 5.7 score on a scale | Standard Deviation 2.2 |
| Standard Bupivacaine Group | Pain Scores | Day 2 | 5.9 score on a scale | Standard Deviation 2.6 |
| Standard Bupivacaine Group | Pain Scores | Day 1 | 4.5 score on a scale | Standard Deviation 2.4 |
Secondary
Quadriceps Strength
Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine Group | Quadriceps Strength | 16.5 Pounds of Force | Standard Deviation 11 |
| Standard Bupivacaine Group | Quadriceps Strength | 19.2 Pounds of Force | Standard Deviation 12.8 |