Liposomal Bupivacaine in Adductor Canal Blocks (ACB)

University of Miami

Status and phase: Withdrawn; Phase 4

Conditions: Peripheral Nerve Block; Adductor Canal Block; Opioid Use; Arthroplasty Complications

Treatments: Procedure: Drug: SoC Ropivacaine; Drug: Liposomal bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04539730

20200003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Ropivacaine Standard of Care Group

Active Comparator group

Description:

Participants undergoing elective Total Knee Arthoplasty (TKA) surgery that are randomized to the control group will undergo an ultrasound-guided Adductor Canal Block (ACB) with standard of care (SoC) Ropivacaine post TKA surgery.

Treatment:

Procedure: Drug: SoC Ropivacaine

Liposomal Bupivacaine Intervention Group

Experimental group

Description:

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

Treatment:

Drug: Liposomal bupivacaine

Procedure: Drug: SoC Ropivacaine