Block and Periarticular Injection Study

The Effect of Regional Anesthesia and Periarticular Injection and Versus Periarticular Injection Alone on Early Recovery After Total Knee Arthroplasty: A Prospective Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: regional anesthesia and PAI; Drug: PAI

Detailed Description

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
• Enrollment (Actual): 174
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Creve Coeur, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block and Periarticular injection; regional anesthesia (Adductor canal block +IPACK) and Periarticular injection	Drug: regional anesthesia and PAI; this is the block portion of the study; Other Names: adductor canal block; periarticular injection; Drug: PAI; this is the no block portion of the study; Other Names: Periarticular injections
Active Comparator: Periarticular injectin alone; Periarticular injection alone	Drug: PAI; this is the no block portion of the study; Other Names: Periarticular injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively	pain score 0-10 10 being more pain	at 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	postop day 2
Daily Step Count at 2 Weeks Postop	step count throught fitbit	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.	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.	baseline % of very good sleep and fairly good sleep
Oxford Knee Score	oxford knee survey through app, 0-48 scale 0 being min and 48 being max 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.	7 days postop
Oxford Knee Score	oxford knee survey through app, 0-48 scale 0 being min and 48 being max 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.	14 days postop
Sleep Quality Via App Surveys With Range of 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 7 day timepoint.	7 days postop % of fairly good to very good sleep
Sleep Quality Via App Surveys With Range of Very Good Sleep to 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 14 day timepoint.	14 days postop % of very good sleep to fairly good sleep

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Andrew Schneider, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Actual): May 12, 2025
• Study Completion (Actual): May 12, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Anesthesia and Analgesia; Anesthesia; Anesthesia, Conduction
• Other Study ID Numbers: 202311211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No