NCT04749615

Does PAI Reduce Pain After TKA Among Knee Arthroplasty Patients Receiving ACB & IPACK?

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 (ACB&IPACK)? A Blinded, Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 25 Years – 80 Years
• Healthy volunteers: Not accepted

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 ACB/IPACK without PAI as effective as ACB/IPACK with PAI for TKA patients? Participants will be assigned to one of the following groups at random: * ACB/PACK with PAI * ACB/IPACK 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 ACB/IPACK to PAI improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). TKA patients receiving PAI + ACB/IPACK (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on POD1: 1.7 +/- 1.4 (mean +/- SD, NRS, 0-10 scale). The opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents). It is not clear if the PAI component is necessary, given the theoretically nearly complete analgesic effects of the ACB/IPACK 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 ACB/IPACK, it is not desirable to perform unnecessary procedures. In this study, we seek to compare the efficacy of ACB/IPACK with and without PAI in TKA patients.

Conditions

• Total Knee Athroplasty

Interventions

Type	Name	Description
DRUG	Periarticular Injection (PAI)	PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
DRUG	Saline Control Periarticular Injection (PAI)	equal volume of saline will be used in place of analgesics used in PAI injections

Timeline

• Start date: 2020-12-17
• Primary completion: 2022-04-01
• Completion: 2022-07-01
• First posted: 2021-02-11
• Last updated: 2024-12-27
• Results posted: 2024-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study