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

NCT03182933 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2016-0869
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

10 meter walk test; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• 10 Meter Walk Test

  Time to comfortably walk 10 meters as deemed safe by physical therapy

  24 hours

Secondary Outcomes (4)

• Pain Scores

  Day 0, Day 1, Day 2, Day 3

• Opioid Consumption in Morphine Equivalents

  Day 0 (OR), Day 0 (PACU), Day 1, Day 2, Day 3

• Number of Participants Who Experienced Nausea

  Day 0, Day 1, Day 2, Day 3

• Quadriceps Strength

  24 hours

Study Arms (2)

Liposomal bupivacaine group

EXPERIMENTAL

20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block)

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

Standard bupivacaine group

ACTIVE COMPARATOR

20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block)

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

Interventions

Peripheral Nerve Blockade DRUG

Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization

Liposomal bupivacaine group; Standard bupivacaine group

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

Liposomal bupivacaine group; Standard bupivacaine group

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

Liposomal bupivacaine group; Standard bupivacaine group

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

Liposomal bupivacaine group; Standard bupivacaine group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is scheduled for elective unilateral TKA;
• The subject is ≥ 18 years and ≤ 80 years;
• The subject's weight is between 65-130 kg;
• The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural);
• The patient agrees to receive an adductor canal block;
• American Society of Anesthesiologists class 1-3.

You may not qualify if:

• Subject is \< 18 years of age or \>80 years of age;
• Subject is non-English speaking;
• Subject is known or believed to be pregnant;
• Subject is a prisoner;
• Subject has impaired decision-making capacity per discretion of the Investigator;
• Symptomatic untreated gastroesophageal reflux or otherwise at risk for perioperative aspiration;
• Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate;
• Significant pre-existing neuropathy on the operative limb;
• Significant renal, cardiac or hepatic disease per discretion of the investigator;
• American Society of Anesthesiologists class 4-5;
• Known hypersensitivity and/or allergies to local anesthetics;
• Chronic Opioid Use (daily or almost daily use of opioids for \> 3 months).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

The American Center

Madison, Wisconsin, 53718, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Laura Zitur - research program manager
• Organization: University of Wisconsin

lzitur@wisc.edu

6082638118

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2017
• First Posted: June 9, 2017
• Study Start: May 30, 2017
• Primary Completion: July 16, 2018
• Study Completion: July 16, 2018
• Last Updated: June 25, 2019
• Results First Posted: June 25, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)