Clinical trial NCT03182933: Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
Official title: Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: 10 meter walk test
Opioid consumption
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: 10 Meter Walk Test
timeFrame: 24 hours
Secondary outcomes:
measure: Pain Scores
timeFrame: Day 0, Day 1, Day 2, Day 3
measure: Opioid Consumption in Morphine Equivalents
timeFrame: Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3
measure: Number of Participants Who Experienced Nausea
timeFrame: Day 0, Day 1, Day 2, Day 3
measure: Quadriceps Strength
timeFrame: 24 hours
Other outcomes:
Locations:
city: Madison
country: United States
facility: The American Center
state: Wisconsin
Study officials:
References: