Block and Periarticular Injection Study

Phase 4

• Conditions: Pain, Postoperative
• Interventions: Drug: PAI; Drug: regional anesthesia and PAI

• Registration Number: NCT06410612
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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 pos...

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...

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2024-03-04
• Study First Submitted: 2024-03-11
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Periarticular injectin alone	PAI	Periarticular injection alone
Block and Periarticular injection	PAI	regional anesthesia (Adductor canal block +IPACK) and Periarticular injection
Block and Periarticular injection	regional anesthesia and PAI	regional anesthesia (Adductor canal block +IPACK) and Periarticular injection

Primary Outcome Measures

Name	Time	Method
Mean Visual Analog Scale (VAS) pain score for 2 weeks postoperatively	at 2 weeks	pain score 0-10 10 being more pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Creve Coeur, Missouri, United States