Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353233
Recruitment Status : Suspended (COVID-19 HOLD)
First Posted : November 27, 2017
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Primary Total Knee Arthroplasty Physical Therapy Pain Knee Extension Drug: Ropivacaine Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block Drug: Saline Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Actual Study Start Date : May 3, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 2, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Experimental: iPACK Block Group
A nerve block technique using a numbing medication called ropivacaine.
Drug: Ropivacaine
Local anesthetic (numbing drug)
Other Name: Naropin

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

Placebo Comparator: Sham Group
The same nerve block technique as above, however using an inactive solution of salt water.
Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
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

Drug: Saline
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Other Name: Salt water placebo




Primary Outcome Measures :
  1. Knee Hyperextension [ Time Frame: Within 8 hours ]
    Ability to hyperextend the knee after surgery


Secondary Outcome Measures :
  1. Ambulation [ Time Frame: Within 24 hours ]
    Walking after surgery

  2. Timed-up-and-go (TUG) test [ Time Frame: Within 24 hours ]
    Getting up and moving after surgery

  3. Numeric pain score, as measure by numerical rating scale (NRS) 11 [ Time Frame: 24 hours ]
    Numeric pain score, as measure by numerical rating scale (NRS) 11

  4. Cumulative opioid consumption [ Time Frame: 24 hours ]
    Total amount of opioids used



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353233


Locations
Layout table for location information
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03353233    
Other Study ID Numbers: Pro00070573
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Layout table for additional information
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.: Yes
Keywords provided by Duke University:
iPACK
Interspace between the Popliteal Artery and Capsule of the Knee
Posterior Capsule block
Nerve Block
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents