Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty

NCT02166632 | Completed

• 1 other identifier: BH130401
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine quantitative and qualitative differences in post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who receive administration of a newly approved, long acting local anesthetic branded as ExparelTM (bupivacaine liposome injectable suspension) introduced by one of two different administration methods. Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly into the joint capsule at the conclusion of the surgery, effectively bathing the joint in anesthetic solution. Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9) standard sites at the conclusion of the surgery.

Conditions

Osteoarthritis, Knee

Keywords

Knee arthroplasty; Exparel; Bupivacaine liposome; Total knee replacement; Pain control

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale for Pain

  Pre-Surgical visual analog scale for pain will be administered up to 2 months pre-surgery. Post-Surgical visual analog scales will be administered as a "pain journal" in which patients will record their level of pain twice a day, once in the morning, and once in the evening for 1 week.

  8 weeks pre-surgery (Baseline/Day 0) and every day for 1 week, post-surgery (Day 1, 2, 3, 4, 5, 6, 7)

Secondary Outcomes (1)

• Change in Oxford Knee Score

  8 weeks pre-surgery (baseline) and 4 weeks post surgery (Day 28)

Study Arms (2)

Intracapsular Injection

EXPERIMENTAL

Patients in the experimental group will undergo direct injection of ExparelTM into the knee joint; once the total knee replacement (arthroplasty) has been completed, patients will receive a given amount of ExparelTM administered during surgery into the joint where the knee replacement (arthroplasty) (TKA) was performed.

Procedure: Intracapsular Injection

Periarticular Injection

ACTIVE COMPARATOR

Patients in this group will undergo local injection of ExparelTM to help to reduce post-surgery pain. Once the total knee replacement (arthroplasty) has been completed, patients in this group will receive a given amount of ExparelTM administered during surgery into the soft tissues around the bone where the knee replacement (arthroplasty) (TKA) was performed.

Procedure: Periarticular Injection

Interventions

Intracapsular Injection PROCEDURE

The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication.

Also known as: Intracapsular injection of bupivacaine liposome (ExparelTM)

Intracapsular Injection

Periarticular Injection PROCEDURE

The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint

Also known as: Periarticular injection of bupivacaine liposome (ExparelTM)

Periarticular Injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be over the age of 18
• Patients must have a preoperative diagnosis of osteoarthritis of the knee requiring total knee arthroplasty

You may not qualify if:

• Allergy to ExparelTM or certain other local anesthetic agents
• Pregnant females or females who think they may become pregnant
• Markedly abnormal kidney function or renal disease
• History of substance abuse
• History of chronic pain requiring medication
• Had a previous total knee arthroplasty on the same knee which is being replaced (revision total knee arthroplasty)
• Had a previous partial knee arthroplasty, such as a unicompartmental knee arthroplasty on the same knee (also a revision total knee arthroplasty)

Sponsors & Collaborators

• Broward Health: lead

Study Sites (1)

Broward Health Sports Medicine

Fort Lauderdale, Florida, 33316, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Agnosia

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William V Burke, M.D.

  Broward Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon, Broward Health

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 18, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)