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

Pain Clinical Trial

Official title:

Impact of Liposomal Bupivacaine Injected for Adductor Canal Block on Recovery Profile and Block Characteristics Following Total Knee Arthroplasty.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03182933
• Other study ID #: 2016-0869
• Status: Terminated
• Phase: Phase 4
• Start date: May 30, 2017
• Est. completion date: July 16, 2018

Study information

• Verified date: June 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: July 16, 2018
• Est. primary completion date: July 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Peripheral Nerve Blockade
Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization

Behavioral:
• 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

Other:
• 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

Device:
• 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

Locations

Country	Name	City	State
United States	The American Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	10 Meter Walk Test	Time to comfortably walk 10 meters as deemed safe by physical therapy	24 hours
Secondary	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
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.	Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3
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	Day 0, Day 1, Day 2, Day 3
Secondary	Quadriceps Strength	Quadriceps Strength is measured in pounds of force using the kiio device, reported as the highest value of 3 collected.	24 hours