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: Enrolling by invitation
• 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 (Estimated): 200
• 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
daily opioid consumption	opioid medications survey	daily up to 2 weeks postop
daily resting Visual Analog Scale (VAS) score	Pain score survey 0-10, 10 being more pain	daily up to 2 weeks postop
daily step count	step count throught fitbit	daily up to 2 weeks postop
length of stay	in hospital stay	postop day 1
complications	Number of participants with complications such as revision, infection, etc	14 days postop
knee range of motion	range of motion daily through app exercises	daily through app and knee brace up to 2 weeks postop
Oxford knee score	oxford knee survey through app, 0-48 scale 0 being min and 48 being max	weekly up to 2 weeks postop
sleep quality	sleep quality through app surveys and fitbit data	daily up to 2 weeks postop

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 (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 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): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• 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