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

Phase 4
Completed
Conditions
Primary Total Knee Arthroplasty
Pain
Knee Extension
Physical Therapy
Knee Osteoarthritis
Interventions
Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
Drug: 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
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sham GroupInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockThe same nerve block technique as above, however using an inactive solution of salt water.
Sham GroupSalineThe same nerve block technique as above, however using an inactive solution of salt water.
iPACK Block GroupInterspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockA nerve block technique using a numbing medication called ropivacaine.
iPACK Block GroupRopivacaineA nerve block technique using a numbing medication called ropivacaine.
Primary Outcome Measures
NameTimeMethod
Number of Participants Able to Hyperextend the Knee After SurgeryWithin 8 hours

Ability to hyperextend the knee after surgery

Secondary Outcome Measures
NameTimeMethod
Cumulative Opioid Consumption24 hours

Total amount of opioids used

Ambulation as Measured by Distance Walked After SurgeryPost-operative Day 0
Pain as Measure by Numerical Rating Scale (NRS) 1124 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

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