Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410612
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2024-03-11
Brief Title:
Block and Periarticular Injection Study
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty A Prospective Randomized Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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 the study is to compare two types of perioperative analgesic modalities adductor canal block plus interspace between popliteal artery and capsule of the knee IPACK block and periarticular injection versus periarticular injection alone to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty
Detailed Description:
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty TKA has led to improvements in perioperative pain control expedited recovery times and shorter hospital stays1-3 Periarticular injections PAIs adductor canal blocks ACBs and interspace between popliteal artery and capsule of the knee IPACK blocks are commonly utilized as part of contemporary multimodal analgesia protocols but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4 There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing increased costs and small risks associated with a regional block Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA Therefore the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs PAI alone for pain management and functional recovery in the early postoperative period following TKA
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon
Group 1 regional anesthesia ACB IPACK and PAI Group 2 PAI alone
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon
Group 1 regional anesthesia ACB IPACK and PAI Group 2 PAI alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None