Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04749615
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2021-02-05
Brief Title:
Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB IPACK
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Does Periarticular Injection PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving Adductor Canal Block and Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee ACBIPACK A Blinded Randomized Controlled Trial
Status:
COMPLETED
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 goal of this clinical trial is to determine whether Periarticular Injection PAI alongside Adductor Canal Block ACB and Infiltration between the Popliteal Artery and Capsule of the Knee IPACK block can decrease post-operative pain in patients undergoing primary total knee arthroplasty The main question it aims to answer is
Is ACBIPACK without PAI as effective as ACBIPACK with PAI for TKA patients
Participants will be assigned to one of the following groups at random
ACBPACK with PAI
ACBIPACK with saline injection
Participants will also be asked to complete pre- and post-operative questionnaires
Is ACBIPACK without PAI as effective as ACBIPACK with PAI for TKA patients
Participants will be assigned to one of the following groups at random
ACBPACK with PAI
ACBIPACK with saline injection
Participants will also be asked to complete pre- and post-operative questionnaires
Detailed Description:
Kim et al 2019 have shown that addition of ACBIPACK to PAI improves analgesic outcomes the nerve blocks reduced pain with ambulation and reduced opioid consumption TKA patients receiving PAI ACBIPACK along with a comprehensive multimodal analgesic program had low pain scores with ambulation on POD1 17 - 14 mean - SD NRS 0-10 scale The opioid consumption in the first 24 hours was 406 - 321 mg oral morphine equivalents
It is not clear if the PAI component is necessary given the theoretically nearly complete analgesic effects of the ACBIPACK block Additionally anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not without obvious large differences in analgesic outcomes While there may be a belt and suspenders advantage to using PAI in addition to ACBIPACK it is not desirable to perform unnecessary procedures
In this study we seek to compare the efficacy of ACBIPACK with and without PAI in TKA patients
It is not clear if the PAI component is necessary given the theoretically nearly complete analgesic effects of the ACBIPACK block Additionally anecdotal evidence indicates that some surgeons at HSS routinely use the PAI and some do not without obvious large differences in analgesic outcomes While there may be a belt and suspenders advantage to using PAI in addition to ACBIPACK it is not desirable to perform unnecessary procedures
In this study we seek to compare the efficacy of ACBIPACK with and without PAI in TKA patients
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?:
True
Is an FDA AA801 Violation?:
None