Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

NCT ID: NCT02863120

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-12-31

Brief Summary

This study is being done to evaluate the outcomes of patients undergoing total knee replacement with two different methods of local pain control:shots of liposomal bupivacaine, a long acting anesthetic, directly into the knee during surgery or anesthetic delivered continuously to the adductor canal to provide long term pain relief. The goal is to try to find a standard protocol that provides the greatest pain relief for patients undergoing total knee replacement.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal bupivacaine

Periarticular infiltration of 20cc of liposomal bupivacaine with 10cc of normal saline and 30cc of bupivacaine HCl administered prior to cementation of knee implants

Group Type: ACTIVE_COMPARATOR

liposomal bupivacaine

Intervention Type: DRUG

bupivacaine HCl

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Adductor canal and tibial nerve block

Preoperative tibial nerve block with 15cc bupivacaine HCl and adductor canal block with 20cc adductor canal block. Postoperative continuous adductor canal block with 550cc ropivacaine at 8cc per hour

Group Type: ACTIVE_COMPARATOR

bupivacaine HCl

Intervention Type: DRUG

Ropivacaine

Intervention Type: DRUG

Interventions

liposomal bupivacaine

Intervention Type: DRUG

bupivacaine HCl

Intervention Type: DRUG

Ropivacaine

Intervention Type: DRUG

Saline

Intervention Type: DRUG

Other Intervention Names

Exparel; Marcaine; Naropin

Eligibility Criteria

Inclusion Criteria

• Male or non-pregnant female between the ages of 18-65
• Patients willing and able to sign the informed consent
• Patients able to comply with follow-up requirements including self-evaluations
• Patients requiring a primary total knee replacement
• Patients with a diagnosis of osteoarthritis, traumatic arthritis, or avascular necrosis

Exclusion Criteria

• Revision total knee arthroplasty
• Bilateral total knee arthroplasty
• Patients with inflammatory arthritis
• Patients with a body mass index (BMI) > 40
• Allergy to ropivacaine, bupivacaine, or other local anesthetic agents
• Current use of opioid drugs
• Patients with a history of total or unicompartmental reconstruction of the affected joint
• Patients that have had a high tibial osteotomy or femoral osteotomy
• Patients with neuromuscular or neurosensory deficiency, which would limit the ability to assess pain levels
• Patients with a systemic or metabolic disorder leading to progressive bone deterioration
• Patients that are immunologically compromised, or receiving chronic steroids (>30 days), excluding inhalers
• Patients' bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis
• Patients with knee fusion to the affected joint
• Patients with an active or suspected latent infection in or about the knee joint
• Patients that are prisoners

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Orthopaedics, Sports and Rehabilitation Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tyler D Goldberg, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Orthopedics

Locations

Texas Orthopedics

Austin, Texas, United States

Countries

United States

Other Identifiers

TG-EXP-160402

Identifier Type: -

Identifier Source: org_study_id