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

NCT ID: NCT04749615

Last Updated: 2024-12-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-17

Study Completion Date

2022-07-01

Brief Summary

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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

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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

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Total Knee Athroplasty

Keywords

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TKA PAI ACB IPACK Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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No PAI + ACB & IPACK

Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)

Group Type PLACEBO_COMPARATOR

Saline Control Periarticular Injection (PAI)

Intervention Type DRUG

equal volume of saline will be used in place of analgesics used in PAI injections

PAI + ACB & IPACK

Active intervention: Periarticular injection: one deep injection prior to cementation and then a second more superficial injection prior to closure. The deep injection will consist of bupivacaine 0.25% with 1:200,000 epinephrine, 30 cc; morphine, 8 mg/ml, 1cc; methylprednisolone, 40 mg/ml, 1 ml; cefazolin, 500 in 10 ml; normal saline, 22cc. The superficial injection will be 20 ml 0.25% bupivacaine

Group Type ACTIVE_COMPARATOR

Periarticular Injection (PAI)

Intervention Type DRUG

PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.

Interventions

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Periarticular Injection (PAI)

PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.

Intervention Type DRUG

Saline Control Periarticular Injection (PAI)

equal volume of saline will be used in place of analgesics used in PAI injections

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Planned use of regional anesthesia
* Ability to follow the major components of the study protocol
* English speaking (Secondary outcomes include questionnaires validated in English only)

Exclusion Criteria

* Patients younger than 25 years old and older than 80
* Non-English speaking
* Patients intending to receive general anesthesia
* Contraindication to nerve blocks or peri-articular injection
* Patients with an ASA of IV or higher
* Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 30 ml/min)
* Patients with major prior ipsilateral open knee surgery
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Chronic opioid use (taking opioids for longer than 3 months)
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques YaDeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2019-2096

Identifier Type: -

Identifier Source: org_study_id