Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Patient Outcomes With Periarticular Liposomal Bupivacaine Injection vs Adductor Canal Block After Primary Total Knee Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02863120
• Other study ID #: TG-EXP-160402
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Texas Orthopaedics, Sports and Rehabilitation Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• liposomal bupivacaine

• bupivacaine HCl

• Ropivacaine

• Saline

Locations

Country	Name	City	State
United States	Texas Orthopedics	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Orthopaedics, Sports and Rehabilitation Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay (LOS, in days)		Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days
Primary	Time to ambulation (in hours)		2-6 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 0	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	6 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 1	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	24 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 2	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	48 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 3	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	72 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 4	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	96 hours
Secondary	Pain as assessed by visual analog scale (VAS) on postoperative day 5	Pain levels will be determined on postoperative day 0, 1, 2, 3, 4, and 5	120 hours
Secondary	Opioid consumption in oral morphine equivalents (OMEs, in milligrams)		Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days.
Secondary	Postoperative complications and adverse events		2 weeks