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.

Study Overview

• Status: Completed
• Conditions: Pain; Knee Osteoarthritis; Physical Therapy; Primary Total Knee Arthroplasty; Knee Extension
• Intervention / Treatment: Drug: Ropivacaine; Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Drug: Saline

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iPACK Block Group; A nerve block technique using a numbing medication called ropivacaine.	Drug: Ropivacaine; Local anesthetic (numbing drug); Other Names: 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 Names: Salt water placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Able to Hyperextend the Knee After Surgery	Ability to hyperextend the knee after surgery	Within 8 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ambulation as Measured by Distance Walked After Surgery		Post-operative Day 0
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
Cumulative Opioid Consumption	Total amount of opioids used	24 hours

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Actual): January 22, 2021
• Study Completion (Actual): January 23, 2021

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Nerve Block; iPACK; Interspace between the Popliteal Artery and Capsule of the Knee; Posterior Capsule block
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: Pro00070573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.

Drug and device information, study documents

• 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