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

February 8, 2016 updated by: W Vincent Burke, MD, Broward Health

Prospective, Randomized Comparison of Postoperative Pain Control Results of Peri-articular Local Injection and Intra-capsular Injectinon of Bupivacaine Liposome Injectable Suspension After Total Knee Arthroplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is being done to determine if a difference exists between two methods of intraoperative (during surgery) administration of a long-acting local anesthetic (pain relief).

Local pain relief medications are accepted as standard of care as a part of a comprehensive plan for pain relief following a total knee replacement (arthroplasty) (TKA). We expect that the addition of ExparelTM to the usual post-surgery pain control medicines and procedures will result in less need for additional pain medication. It is possible that local injection into the tissue around the total knee replacement joint (periarticular tissues) may provide more effective pain relief than injection directly into the joint (intracapsular) itself, or vice versa. It is also possible that pain relief with either method is approximately equivalent. On the day of surgery, each patient will undergo total knee arthroplasty and cared for utilizing the standard protocol for all patients that undergo total knee arthroplasty at Broward Health Medical Center.

Patients in Group 1 will receive the same amount of ExparelTM injected intracapsularly. Those in is Group 2 will receive a standardized medication regimen including ExparelTM by local infiltration into the periarticular tissues at the conclusion of their TKA procedure. Study participants will undergo injection in this manner until the conclusion of the study.

All subjects will be provided the same methods of postoperative pain control following their TKA surgery as those patients not enrolled in the study.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Broward Health Sports Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intracapsular Injection
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
The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication.
Other Names:
  • Intracapsular injection of bupivacaine liposome (ExparelTM)
ACTIVE_COMPARATOR: Periarticular Injection
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
The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint
Other Names:
  • Periarticular injection of bupivacaine liposome (ExparelTM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale for Pain
Time Frame: 8 weeks pre-surgery (Baseline/Day 0) and every day for 1 week, post-surgery (Day 1, 2, 3, 4, 5, 6, 7)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Oxford Knee Score
Time Frame: 8 weeks pre-surgery (baseline) and 4 weeks post surgery (Day 28)
Pre-surgical oxford knee questionnaires will be administered up to 2 months pre-surgery. Post-surgical questionnaires will be administered at the patient's first follow-up office visit, approximately 4 weeks post-surgery.
8 weeks pre-surgery (baseline) and 4 weeks post surgery (Day 28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Broward Health

Investigators

  • Principal Investigator: William V Burke, M.D., Broward Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

June 13, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (ESTIMATE)

June 18, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BH130401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Osteoarthritis, Knee

Clinical Trials on Intracapsular Injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe