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Completed

NCT Number: NCT03353233

Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.

The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a "nerve block") that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Extension Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Physical Therapy Primary Total Knee Arthroplasty Rheumatic Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Hospital

Durham, North Carolina, 27713, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • English speaking
  • Between 18 and 75 years old
  • American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty

Exclusion criteria

  • ASA 4 or 5
  • Revision knee arthroplasty
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Acute knee dislocation/fracture
  • Infection at the site of block placement
  • Age under 18 years old or greater than 75 years old
  • Pregnant women
  • Intolerance/allergy to local anesthetics
  • Weight <50 kg
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Treatment and study plan

Ropivacaine

Drug

Local anesthetic (numbing drug)

Other names: Naropin

Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block

Procedure

An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.

Other names: iPACK, Posterior Capsule

Saline

Drug

An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.

Other names: Salt water placebo

Primary outcomes

  1. Number of Participants Able to Hyperextend the Knee After Surgery

    Time frame: Within 8 hours

    Ability to hyperextend the knee after surgery

Secondary outcomes

  1. Ambulation as Measured by Distance Walked After Surgery

    Time frame: Post-operative Day 0

  2. Pain as Measure by Numerical Rating Scale (NRS) 11

    Time frame: 24 hours

    The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").

  3. Cumulative Opioid Consumption

    Time frame: 24 hours

    Total amount of opioids used

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 27, 2017
Registry last updated
Dec 21, 2021

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.

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