NCT03653416

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 3, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

August 28, 2018

Results QC Date

September 11, 2020

Last Update Submit

October 11, 2020

Conditions

Osteo Arthritis Knee

Keywords

Total knee arthroplastyPeri articular infiltrationPack blockAdductor canal catheter

Outcome Measures

Primary Outcomes (1)

  • Narcotic Consumption

    Narcotic consumption in the first 24 hours

    24 hours

Secondary Outcomes (6)

  • Visual Analogue Score (VAS) for Pain

    at 6, 12, 18, and 24 hours post procedure

  • Time to First Dose of Narcotic Administration

    up to 24 hours

  • PACU Length of Stay

    average 24 hours

  • Number of Participants With Pain by Location

    24 hours

  • Ambulation Distance

    Post-op Day 1

  • +1 more secondary outcomes

Study Arms (2)

Ipack group

EXPERIMENTAL

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: IpackDrug: BupivacaineProcedure: Peri Articular Infiltration

Pai (peri articular) group

ACTIVE COMPARATOR

Patients will receive adductor canal catheter and peri articular infiltration.

Procedure: Peri Articular Infiltration

Interventions

IpackDEVICE

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

Ipack group
BupivacaineDRUG

20 cc of bupivacaine(o.25%) injection

Ipack group
Peri Articular InfiltrationPROCEDURE

Adductor Canal Catheter and Peri Articular Infiltration

Also known as: PAI
Ipack groupPai (peri articular) group

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA (American Society of Anesthesiology) class I-IV
  • age 18-75.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (2)

  • 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.

    PMID: 29721648BACKGROUND

  • 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.

    PMID: 35944566DERIVED

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Poonam Pai B. H
Organization
Icahn School of Medicine at Mount Sinai
poonam.paibantwalhebbalasankatte@mountsinai.org
347-569-4816

Study Officials

  • Yan H Lai, MD,MPH

    Ichan School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

March 1, 2018

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

November 3, 2020

Results First Posted

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)