Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
- Conditions
- Primary Total Knee ArthroplastyPainKnee ExtensionPhysical TherapyKnee Osteoarthritis
- Interventions
- Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockDrug: Saline
- Registration Number
- NCT03353233
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- English speaking
- Between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Group Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block The same nerve block technique as above, however using an inactive solution of salt water. Sham Group Saline The same nerve block technique as above, however using an inactive solution of salt water. iPACK Block Group Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block A nerve block technique using a numbing medication called ropivacaine. iPACK Block Group Ropivacaine A nerve block technique using a numbing medication called ropivacaine.
- Primary Outcome Measures
Name Time Method Number of Participants Able to Hyperextend the Knee After Surgery Within 8 hours Ability to hyperextend the knee after surgery
- Secondary Outcome Measures
Name Time Method Cumulative Opioid Consumption 24 hours Total amount of opioids used
Ambulation as Measured by Distance Walked After Surgery Post-operative Day 0 Pain as Measure by Numerical Rating Scale (NRS) 11 24 hours The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").
Trial Locations
- Locations (1)
Duke University Hospital
🇺🇸Durham, North Carolina, United States