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Completed

NCT Number: NCT03653416

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

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.

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Key information

Conditions

Osteo Arthritis Knee

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ipack

Device

IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.

Bupivacaine

Drug

20 cc of bupivacaine(o.25%) injection

Peri Articular Infiltration

Procedure

Adductor Canal Catheter and Peri Articular Infiltration

Other names: PAI

Primary outcomes

  1. Narcotic Consumption

    Time frame: 24 hours

    Narcotic consumption in the first 24 hours

Secondary outcomes

  1. 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.

  2. Time to First Dose of Narcotic Administration

    Time frame: up to 24 hours

  3. PACU Length of Stay

    Time frame: average 24 hours

    Post-Anesthesia Care Unit (PACU) length of stay (LOS)

  4. Number of Participants With Pain by Location

    Time frame: 24 hours

    Location of knee pain as anterior/posterior, medial/lateral

  5. Ambulation Distance

    Time frame: Post-op Day 1

    Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT

  6. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2018
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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