Phase 4
N=99
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Osteo Arthritis Knee
Bottom Line
View on ClinicalTrials.gov: NCT03653416 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Narcotic Consumption — 15.87; 13.67 morphine equivalents, mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ipack (Device); Bupivacaine (Drug); Peri Articular Infiltration (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Narcotic Consumption |
15.87; 13.67 | — |
| SECONDARY Visual Analogue Score (VAS) for Pain |
0.93; 0.93; 0.76; 0.93; 0.74; 1.41 | — |
| SECONDARY Time to First Dose of Narcotic Administration |
1.5; 0.25 | — |
| SECONDARY PACU Length of Stay |
3.00; 3.00 | — |
| SECONDARY Number of Participants With Pain by Location |
1; 0; 4; 18; 10; 7 | — |
| SECONDARY Ambulation Distance |
50; 45 | — |
| SECONDARY Bartels Index |
47; 39 | — |
Summary
Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.
Eligibility Criteria
Inclusion Criteria
- ASA (American Society of Anesthesiology) class I-IV
- age 18-75.
Exclusion Criteria
- ASA class V
- morbid obesity
- patient refusal
- patients with chronic pain or on pain medication
- allergy to LA
- patients receiving any additional regional techniques
- coagulopathy
- patients receiving systemic anticoagulation
- local infection and procedures anticipated to last more than 5 hours.
Data sourced from ClinicalTrials.gov (NCT03653416). 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.