Ignite Creation Date:
2024-05-06 @ 2:55 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02166632
Status:
COMPLETED
Last Update Posted:
2016-02-10
First Post:
2014-06-13
Brief Title:
Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
Sponsor:
Broward Health
Organization:
Broward Health
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None