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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03353233
Other study ID # Pro00070573
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
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