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.

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.

Study Overview

• Status: Completed
• Conditions: Total Knee Athroplasty
• Intervention / Treatment: Drug: Saline Control Periarticular Injection (PAI); Drug: Periarticular Injection (PAI)

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: No PAI + ACB & IPACK; Control: saline injection (same injection technique and volumes as described for the active intervention, of normal saline)	Drug: Saline Control Periarticular Injection (PAI); equal volume of saline will be used in place of analgesics used in PAI injections
Active Comparator: 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	Drug: Periarticular Injection (PAI); PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores (NRS, 0-10) with ambulation on POD1	The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will be asked on post operative discharge day 1.	24 hours Post Operative Discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use (cumulative oral morphine equivalents POD0-POD2, 2 weeks, 3 months)	Cumulative opioid consumption in morphine equivalents will be recorded post surgical discharge, 24h post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.	post surgical discharge, 24 hours post surgical discharge, 48 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge.
NRS pain with movement on POD0, POD2, 3 months	The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain during movement. and will be asked post operative discharge, 48 hours post operative discharge, and 3 months post operative discharge.	post operative discharge, 48 hours post operative discharge, and 3 months post operative discharge.
NRS pain score at rest (POD0,POD1, POD2, 3 months)	The NRS (numeric rating scale) is a questionnaire that measures pain on a numeric scale, 0 (no pain) to 10 (worst pain imaginable). The questionnaire will focus on pain without movement involved and will be asked post operative discharge, 24 hours post operative discharge, 48 hours post operative discharge, and 3 months post operative discharge.	post operative discharge, 24 hours post operative discharge, 48 hours post operative discharge, and 3 months post operative discharge
PAIN OUT questionnaire (POD 0, POD1, 2 weeks, 3 months)	The PAIN OUT questionnaire has multiple numeric scale questions on pain relief as well as pain intensity, along with Yes/No questions. There are also questions asking which pain relief techniques were used (multiple choice). A higher pain relief score is a better result than that of a lower score. While a higher pain score a negative result when compared to a lower score. This questionnaire will be asked post operative discharge, 24 hours post operative discharge, 2 weeks post operative discharge, and 3 months post operative discharge.	post surgical discharge, 24 hours post surgical discharge, 2 weeks post surgical discharge, and 3 months post surgical discharge
Quality of Recovery (QOR9) (POD1)	( Quality of Recovery) This questionnaire has three options for scale (not at all, some of the time, most of the time). The questions focus on the overall well being of the patient. The questionnaire will be asked 24 hours post surgical discharge.	24 hours post surgical discharge.
Side effects: Opioid-Related Symptom Distress score (POD1)	The questionnaire uses multiple choice answers ranging from rare-almost consistently, not at all- very much, slight- very severe. The questions focus on reported side effects of opioid use. The questionnaire will be asked 24 hours post surgical discharge.	24 hours post surgical discharge.
Satisfaction with pain management (POD1)	This questionnaire is a numeric scale from 0 (strongly dissatisfied) to 10 ( strongly satisfied). A higher number dictates a better outcome. This will be asked 24 hours post operative discharge.	24 hours post operative discharge.
Blinding assessment; Bang question (POD1)	There is no numeric scale for this questionnaire. It focuses on asking the patient which group they believe they were randomized to and why. This will be asked 24 hours post operative discharge.	24 hours post operative discharge
DN4 Neuropathic Assesment (PreOp, 3months)	The DN4 ( Douleur Neuropathique en 4 Questions) is a Yes/No questionnaire aimed at uncovering neuropathic pain symptoms.	Pre operative, 3 months post operative discharge.
Orthopedic Outcome	The standard KOOS Jr. questionnaire will be asked to evaluate orthopedic outcomes. The KOOS Jr. is non-numerical scale, but rather a wording scale from "none" to "extreme", with "none" dictating a better outcome. The KOOS Jr. is a series of questions that aim to asses potential pain and knee functionality (stiffness and function during activities). The questionnaire will be asked preoperatively, 6 weeks post operative discharge, 3 months post operative discharge, and up to 2 years post operative discharge at routine postoperative visits.	preoperatively, 6 weeks post operative discharge, 3 months post operative discharge, and up to 2 years post operative discharge at routine postoperative visits.

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Knee Arthroplasty; ACB; TKA; PAI; IPACK
• Other Study ID Numbers: 2019-2096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Investigators whose proposed use of the data has been approved by an Independent review committee ("learned intermediary") identified for this purpose and who have signed a DUA.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes