Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty

Phase 4

Completed

• Conditions: Osteo Arthritis Knee
• Interventions: Device: Ipack; Drug: Bupivacaine; Procedure: Peri Articular Infiltration

• Registration Number: NCT03653416
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief 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.

Detailed Description

There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.

There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Results First Submitted: 2020-09-11
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-11
• Last Update Submitted: 2020-10-11
• Results First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ipack group	Ipack	20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.
Ipack group	Bupivacaine	20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.
Ipack group	Peri Articular Infiltration	20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well.
Pai (peri articular) group	Peri Articular Infiltration	Patients will receive adductor canal catheter and peri articular infiltration.

Primary Outcome Measures

Name	Time	Method
Narcotic Consumption	24 hours	Narcotic consumption in the first 24 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Pain by Location	24 hours	Location of knee pain as anterior/posterior, medial/lateral
Ambulation Distance	Post-op Day 1	Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Bartels Index	Post-op Day 1	Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence.
Visual Analogue Score (VAS) for Pain	at 6, 12, 18, and 24 hours post procedure	Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.
Time to First Dose of Narcotic Administration	up to 24 hours
PACU Length of Stay	average 24 hours	Post-Anesthesia Care Unit (PACU) length of stay (LOS)

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States