Phase 4
N=50
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Knee Osteoarthritis · Primary Total Knee Arthroplasty · Physical Therapy · Pain · Knee Extension
Bottom Line
View on ClinicalTrials.gov: NCT03353233 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants Able to Hyperextend the Knee After Surgery — 4; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine (Drug); Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block (Procedure); Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Able to Hyperextend the Knee After Surgery |
4; 3 | — |
| SECONDARY Ambulation as Measured by Distance Walked After Surgery |
120.36; 148.8 | — |
| SECONDARY Pain as Measure by Numerical Rating Scale (NRS) 11 |
4.64; 5 | — |
| SECONDARY Cumulative Opioid Consumption |
47.52; 48.98 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03353233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.