Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

Phase 4

Withdrawn

• Conditions: Opioid Use; Arthroplasty Complications; Adductor Canal Block; Peripheral Nerve Block
• Interventions: Drug: Liposomal bupivacaine

• Registration Number: NCT04539730
• Lead Sponsor: University of Miami

Brief Summary

The purpose of this study is to evaluate whether liposomal bupivacaine is superior to normal bupivacaine in terms of providing better pain control postoperatively after total knee arthroplasty.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-08-31
• Study First Posted: 2020-09-07
• Status Verified: 2021-12
• Study Start: 2021-12-01
• Last Update Submitted: 2021-12-06
• Last Update Posted: 2021-12-22
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. The subject is scheduled for elective unilateral primary TKA
2. The subject is ≥ 18 years
3. The subject's primary anesthesia care team has planned for a neuraxial anesthetic (i.e. spinal, epidural or combined-spinal epidural)
4. The patient consents for an adductor canal block
5. Willing and able to sign an informed consent.

Exclusion Criteria

1. Patients unwilling or unable to consent to participate in the study.
2. Prisoners.
3. Pregnancy.
4. Reported to have mental illness or belonging to a vulnerable population.
5. Subject is < 18 years of age.
6. Patients receiving general anesthesia for the total knee arthroplasty.
7. Subject has impaired decision-making capacity per discretion of the Investigator.
8. Any condition for which the primary anesthesia care team deems neuraxial anesthesia inappropriate.
9. Significant pre-existing neuropathy on the operative limb.
10. Significant chronic pain disorders (i.e. fibromyalgia, complex regional pain syndrome I & II, among others).
11. Subject has sustained a significant trauma to the operative knee.
12. Chronic Opioid Use (daily or almost daily use of opioids for > 3 months).
13. Known hypersensitivity and/or allergies to local anesthetics.
14. Previous surgery on the affected knee excluding arthroscopic or open meniscectomy.
15. Patients with impaired renal function such that they cannot receive IV Toradol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine Intervention Group	Liposomal bupivacaine	Participants undergoing elective TKA surgery that are randomized to the intervention group will undergo an ultrasound-guided ACB with Liposomal Bupivacaine post TKA surgery.

Primary Outcome Measures

Name	Time	Method
Opioid Use	Up to 2 weeks	Opioid use after SoC TKA surgery will be evaluated as morphine milligram equivalents

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction as per the Knee Society Score	Up to Week 6	The Knee society score has a total score ranging from 100-0. Scores between 100 and 85 points are considered excellent results, scores between 84 and 70 points are considered good results. Scores between 69 and 60 points are considered fair, and scores less than 60 are considered poor results
Post-Operative Pain Score	Up to 5 days	Post-Operative Pain will be measured via a self-reported Visual Analog Scale (VAS) score. The VAS Pain score ranges from 1-10 with 1 being free of pain and 10 being the most pain.
Number of participants requiring narcotic prescriptions	2 weeks	The number of participants that require further narcotic prescriptions will be reported
Distance Ambulated with physical therapist	Up to 5 days	Average daily distance ambulated using the 6 minute walk test
Length of hospitalization	Up to 5 days	Number of days of hospitalization after elective admission for TKA surgery
Incidence of events of PONV	Up to 5 days	Incidence of post-operative nausea and vomiting (PONV) will be reported throughout the duration of hospitalization
Incidence of urinary retention from narcotic use	2 Weeks	Incidence of urinary retention from narcotic use will be measured via the need for urethral catheterization.