Block and Periarticular Injection Study

Washington University School of Medicine174 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

174

Conditions

Pain, Postoperative

Interventions

regional anesthesia and PAIDRUG

this is the block portion of the study

PAIDRUG

this is the no block portion of the study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Planning to undergo Unilateral primary total knee arthroplasty. * 18 and up * Willing to sign informed consent * Willing to return for all follow-up visits * Smartphone or tablet device capable of running the FocusMotion platform Exclusion Criteria: * BMI \> 45 * Preexisting functionally limiting neurologic disorders * Hepatic or renal insufficiency * History of unprovoked venous thromboembolism * Inability to complete baseline functional testing * Chronic opioid or gabapentin and pregabalin use (chronic defined as use \>5 days per week prior to the surgical procedure) * Allergy or intolerance to trial medications * Planned admission to a postoperative rehabilitation facility * Planned general anesthesia * Receiving workers compensation or disability payments

Locations (1)

Washington University School of Medicine

Creve Coeur, Missouri, United States

Outcomes

Primary Outcomes

Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively

pain score 0-10 10 being more pain

Time frame: at 2 weeks

Secondary Outcomes

Opioid Use

opioid medications survey Opioids calculated MMEs (morphine milligram equivalents) milligrams of opioids correlates with the morphine equivalents. Morphine equivalents are standard units used to compare the analgesic potency of different opioids to a reference dose of oral morphine. They calculate total daily, safe, and effective doses

Time frame: postop day 2

Daily Step Count at 2 Weeks Postop

step count throught fitbit

Time frame: 2 weeks postop

Oxford Knee Score

oxford knee survey through app, 0-48 scale 0 being min and 48 being max score assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment.

Time frame: baseline

Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep

sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the baseline timepoint.

Time frame: baseline % of very good sleep and fairly good sleep

Oxford Knee Score

Data from ClinicalTrials.gov

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