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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03653416
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Lai, 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.

Condition or disease Intervention/treatment Phase
Osteo Arthritis Knee Device: Ipack Drug: Bupivacaine Procedure: Peri Articular Infiltration Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

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 Name: 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 Name: PAI




Primary Outcome Measures :
  1. Narcotic consumption [ Time Frame: 24 hours ]
    Narcotic consumption in the first 24 hours


Secondary Outcome Measures :
  1. Visual Analogue Score (VAS) for pain [ Time Frame: up to first 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: average 24 hours ]
  3. PACU length of stay [ Time Frame: average 24 hours ]
  4. Location of pain [ 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 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 0-20, with lower scores indicating increased disability.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653416


Contacts
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Contact: Poonam Pai, MBBS,MS 212-523-4000 poonam.paibantwalhebbalasankatte@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Yan H Lai, MD,MPH Ichan School of Medicine

Publications:
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Responsible Party: Yan Lai, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03653416    
Other Study ID Numbers: GCO 17-04304
IRB 17-01981 ( Other Identifier: PPHS, ISMMS )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Yan Lai, Icahn School of Medicine at Mount Sinai:
Total knee arthroplasty
Peri articular infiltration
Pack block
Adductor canal catheter
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents