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

NCT ID: NCT03653416

Last Updated: 2020-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-08-01

Brief Summary

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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

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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).

Conditions

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Osteo Arthritis Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ipack

Intervention Type DEVICE

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

Bupivacaine

Intervention Type DRUG

20 cc of bupivacaine(o.25%) injection

Peri Articular Infiltration

Intervention Type PROCEDURE

Adductor Canal Catheter and Peri Articular Infiltration

Pai (peri articular) group

Patients will receive adductor canal catheter and peri articular infiltration.

Group Type ACTIVE_COMPARATOR

Peri Articular Infiltration

Intervention Type PROCEDURE

Adductor Canal Catheter and Peri Articular Infiltration

Interventions

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Ipack

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

Intervention Type DEVICE

Bupivacaine

20 cc of bupivacaine(o.25%) injection

Intervention Type DRUG

Peri Articular Infiltration

Adductor Canal Catheter and Peri Articular Infiltration

Intervention Type PROCEDURE

Other Intervention Names

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PAI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Yan Lai

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan H Lai, MD,MPH

Role: PRINCIPAL_INVESTIGATOR

Ichan School of Medicine

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

Countries

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United States

References

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Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.

Reference Type BACKGROUND
PMID: 29721648 (View on PubMed)

Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9.

Reference Type DERIVED
PMID: 35944566 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB 17-01981

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 17-04304

Identifier Type: -

Identifier Source: org_study_id