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Clinical Trials/NCT03653416
NCT03653416
Completed
Phase 4

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

Icahn School of Medicine at Mount Sinai1 site in 1 country99 target enrollmentMarch 1, 2018

Overview

Phase
Phase 4
Intervention
Ipack
Conditions
Osteo Arthritis Knee
Sponsor
Icahn School of Medicine at Mount Sinai
Enrollment
99
Locations
1
Primary Endpoint
Narcotic Consumption
Status
Completed
Last Updated
5 years ago

Overview

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.

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).

Registry
clinicaltrials.gov
Start Date
March 1, 2018
End Date
August 1, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yan Lai

Assistant Professor

Icahn School of Medicine at Mount Sinai

Eligibility 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.

Arms & Interventions

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.

Intervention: Ipack

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.

Intervention: Bupivacaine

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.

Intervention: Peri Articular Infiltration

Pai (peri articular) group

Patients will receive adductor canal catheter and peri articular infiltration.

Intervention: Peri Articular Infiltration

Outcomes

Primary Outcomes

Narcotic Consumption

Time Frame: 24 hours

Narcotic consumption in the first 24 hours

Secondary Outcomes

  • Ambulation Distance(Post-op Day 1)
  • Bartels Index(Post-op Day 1)
  • Number of Participants With Pain by Location(24 hours)
  • 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)

Study Sites (1)

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