Block and Periarticular Injection Study

NCT06410612 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 202311211
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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 postoperative period following primary total knee arthroplasty.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

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

  pain score 0-10 10 being more pain

  at 2 weeks

Secondary Outcomes (8)

• Opioid Use

  postop day 2

• Daily Step Count at 2 Weeks Postop

  2 weeks postop

• Oxford Knee Score

  baseline

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

  baseline % of very good sleep and fairly good sleep

• Oxford Knee Score

  7 days postop

Study Arms (2)

Block and Periarticular injection

ACTIVE COMPARATOR

regional anesthesia (Adductor canal block +IPACK) and Periarticular injection

Drug: regional anesthesia and PAI; Drug: PAI

Periarticular injectin alone

ACTIVE COMPARATOR

Periarticular injection alone

Drug: PAI

Interventions

regional anesthesia and PAI DRUG

this is the block portion of the study

Also known as: adductor canal block, periarticular injection

Block and Periarticular injection

PAI DRUG

this is the no block portion of the study

Also known as: Periarticular injections

Block and Periarticular injection; Periarticular injectin alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planning to undergo Unilateral primary total knee arthroplasty.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

Creve Coeur, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Andrew Schneider
• Organization: Washington University School of Medicine

schneidera@wustl.edu

314-747-2511

Study Officials

• Andrew Schneider, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients will not know which group they are in
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients will be randomized into 2 groups.

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: May 13, 2024
• Study Start: March 4, 2024
• Primary Completion: May 12, 2025
• Study Completion: May 12, 2025
• Last Updated: April 20, 2026
• Results First Posted: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)