Liposomal Bupivacaine vs Adductor Canal Block in Total Knee Arthroplasty

NCT02863120 | Completed Phase 4

• 1 other identifier: TG-EXP-160402
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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

Keywords

Bupivacaine; Osteoarthritis; Arthritis; Joint Diseases; Ropivacaine; Anesthetics, Local; Anesthetics

Outcome Measures

Primary Outcomes (2)

• Length of stay (LOS, in days)

  Participants will be followed for the duration of their hospital stay, an expected average of 1.5 days

• Time to ambulation (in hours)

  2-6 hours

Secondary Outcomes (8)

• Pain as assessed by visual analog scale (VAS) on postoperative day 0

  6 hours

• Pain as assessed by visual analog scale (VAS) on postoperative day 1

  24 hours

• Pain as assessed by visual analog scale (VAS) on postoperative day 2

  48 hours

• Pain as assessed by visual analog scale (VAS) on postoperative day 3

  72 hours

• Pain as assessed by visual analog scale (VAS) on postoperative day 4

  96 hours

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

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

Drug: liposomal bupivacaine; Drug: bupivacaine HCl; Drug: Saline

Adductor canal and tibial nerve block

ACTIVE COMPARATOR

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

Drug: bupivacaine HCl; Drug: Ropivacaine

Interventions

liposomal bupivacaine DRUG

Also known as: Exparel

Liposomal bupivacaine

bupivacaine HCl DRUG

Also known as: Marcaine

Adductor canal and tibial nerve block; Liposomal bupivacaine

Ropivacaine DRUG

Also known as: Naropin

Adductor canal and tibial nerve block

Saline DRUG

Liposomal bupivacaine

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Orthopaedics, Sports and Rehabilitation Associates: lead

Study Sites (1)

Texas Orthopedics

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Arthritis; Joint Diseases

Interventions

Bupivacaine; Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tyler D Goldberg, MD

  Texas Orthopedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: August 11, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 8, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)