Back to resultsEvaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Primary Purpose
Knee Osteoarthritis, Primary Total Knee Arthroplasty, Physical Therapy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
Saline
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring iPACK, Interspace between the Popliteal Artery and Capsule of the Knee, Posterior Capsule block, Nerve Block
Eligibility 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.
Sites / Locations
- Duke University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
iPACK Block Group
Sham Group
Arm Description
A nerve block technique using a numbing medication called ropivacaine.
The same nerve block technique as above, however using an inactive solution of salt water.
Outcomes
Primary Outcome Measures
Number of Participants Able to Hyperextend the Knee After Surgery
Ability to hyperextend the knee after surgery
Secondary Outcome Measures
Ambulation as Measured by Distance Walked After Surgery
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").
Cumulative Opioid Consumption
Total amount of opioids used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03353233
Brief Title
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Official Title
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2018 (Actual)
Primary Completion Date
January 22, 2021 (Actual)
Study Completion Date
January 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Primary Total Knee Arthroplasty, Physical Therapy, Pain, Knee Extension
Keywords
iPACK, Interspace between the Popliteal Artery and Capsule of the Knee, Posterior Capsule block, Nerve Block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iPACK Block Group
Arm Type
Experimental
Arm Description
A nerve block technique using a numbing medication called ropivacaine.
Arm Title
Sham Group
Arm Type
Placebo Comparator
Arm Description
The same nerve block technique as above, however using an inactive solution of salt water.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
Local anesthetic (numbing drug)
Intervention Type
Procedure
Intervention Name(s)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
Other Intervention Name(s)
iPACK, Posterior Capsule
Intervention Description
An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Salt water placebo
Intervention Description
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Primary Outcome Measure Information:
Title
Number of Participants Able to Hyperextend the Knee After Surgery
Description
Ability to hyperextend the knee after surgery
Time Frame
Within 8 hours
Secondary Outcome Measure Information:
Title
Ambulation as Measured by Distance Walked After Surgery
Time Frame
Post-operative Day 0
Title
Pain as Measure by Numerical Rating Scale (NRS) 11
Description
The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").
Time Frame
24 hours
Title
Cumulative Opioid Consumption
Description
Total amount of opioids used
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Learn more about this trial
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
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