Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty

Phase 4

Terminated

• Conditions: Pain
• Interventions: 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

• Registration Number: NCT03182933
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2017-05-30
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-09
• Primary Completion: 2018-07-16
• Study Completion: 2018-07-16
• Results First Submitted: 2019-05-10
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Results First Posted: 2019-06-25
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine group	Peripheral Nerve Blockade	20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Liposomal bupivacaine group	10 meter walk test on post-operative day 1	20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Liposomal bupivacaine group	In person and over the phone questionnaire	20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Liposomal bupivacaine group	Force transduction of quadriceps strength	20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)
Standard bupivacaine group	10 meter walk test on post-operative day 1	20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Standard bupivacaine group	Force transduction of quadriceps strength	20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Standard bupivacaine group	Peripheral Nerve Blockade	20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)
Standard bupivacaine group	In person and over the phone questionnaire	20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)

Primary Outcome Measures

Name	Time	Method
10 Meter Walk Test	24 hours	Time to comfortably walk 10 meters as deemed safe by physical therapy

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The American Center; 🇺🇸 Madison, Wisconsin, United States