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NCT Number: NCT02166632

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

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Broward Health Sports Medicine

Fort Lauderdale, Florida, 33316, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: Intracapsular injection of bupivacaine liposome (ExparelTM)

Periarticular Injection

Procedure

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Broward Health

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2014
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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