Skip to main content
OpenTrials
Completed

NCT Number: NCT06410612

Block and Periarticular Injection Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Washington University School of Medicine

Creve Coeur, Missouri, 63110, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regional anesthesia and PAI

Drug

this is the block portion of the study

Other names: adductor canal block, periarticular injection

PAI

Drug

this is the no block portion of the study

Other names: Periarticular injections

Primary outcomes

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

    Time frame: at 2 weeks

    pain score 0-10 10 being more pain

Secondary outcomes

  1. Opioid Use

    Time frame: postop day 2

    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

  2. Daily Step Count at 2 Weeks Postop

    Time frame: 2 weeks postop

    step count throught fitbit

  3. Oxford Knee Score

    Time frame: baseline

    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.

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

    Time frame: baseline % 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 baseline timepoint.

  5. Oxford Knee Score

    Time frame: 7 days postop

    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.

  6. Oxford Knee Score

    Time frame: 14 days postop

    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. Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep

    Time frame: 7 days postop % of fairly good to very 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.

  8. Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep

    Time frame: 14 days postop % 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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.