Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA), Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | April 2014 |
| End Date: | February 2016 |
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.
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.
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.
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.
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)
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