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

Mount Sinai Health System logo

Mount Sinai Health System

Status and phase

Completed
Phase 4

Conditions

Osteo Arthritis Knee

Treatments

Device: Ipack
Procedure: Peri Articular Infiltration
Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT03653416
IRB 17-01981 (Other Identifier)
GCO 17-04304

Details and patient eligibility

About

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.

Full 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).

Enrollment

99 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

99 participants in 2 patient groups

Ipack group
Experimental group
Description:
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.
Treatment:
Drug: Bupivacaine
Procedure: Peri Articular Infiltration
Device: Ipack
Pai (peri articular) group
Active Comparator group
Description:
Patients will receive adductor canal catheter and peri articular infiltration.
Treatment:
Procedure: Peri Articular Infiltration

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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