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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353233
• Other study ID #: Pro00070573
• Status: Completed
• Phase: Phase 4
• Start date: May 3, 2018
• Est. completion date: January 23, 2021

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 23, 2021
• Est. primary completion date: January 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Extension
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain
• Physical Therapy
• Primary Total Knee Arthroplasty

Intervention

Drug:
• Ropivacaine
Local anesthetic (numbing drug)

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.

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

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Able to Hyperextend the Knee After Surgery	Ability to hyperextend the knee after surgery	Within 8 hours
Secondary	Ambulation as Measured by Distance Walked After Surgery		Post-operative Day 0
Secondary	Pain as Measure by Numerical Rating Scale (NRS) 11	The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").	24 hours
Secondary	Cumulative Opioid Consumption	Total amount of opioids used	24 hours