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

October 11, 2020 updated by: Yan Lai, Icahn School of Medicine at Mount Sinai

Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School Of Medicine At Mount Sinai

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ipack group
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.
Device: Ipack
IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
Drug: Bupivacaine
20 cc of bupivacaine(o.25%) injection
Procedure: Peri Articular Infiltration
Adductor Canal Catheter and Peri Articular Infiltration
Other Names:
  • PAI
Active Comparator: Pai (peri articular) group
Patients will receive adductor canal catheter and peri articular infiltration.
Procedure: Peri Articular Infiltration
Adductor Canal Catheter and Peri Articular Infiltration
Other Names:
  • PAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Consumption
Time Frame: 24 hours
Narcotic consumption in the first 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score (VAS) for Pain
Time Frame: 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.
at 6, 12, 18, and 24 hours post procedure
Time to First Dose of Narcotic Administration
Time Frame: up to 24 hours
up to 24 hours
PACU Length of Stay
Time Frame: average 24 hours
Post-Anesthesia Care Unit (PACU) length of stay (LOS)
average 24 hours
Number of Participants With Pain by Location
Time Frame: 24 hours
Location of knee pain as anterior/posterior, medial/lateral
24 hours
Ambulation Distance
Time Frame: Post-op Day 1
Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Post-op Day 1
Bartels Index
Time Frame: 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.
Post-op Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Yan H Lai, MD,MPH, Ichan School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 29, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

October 11, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 17-04304
  • IRB 17-01981 (Other Identifier: PPHS, ISMMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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