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

Osteo Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03653416
• Other study ID #: GCO 17-04304
• Secondary ID: IRB 17-01981
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: October 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Narcotic Consumption	Narcotic consumption in the first 24 hours	24 hours
Secondary	Visual Analogue Score (VAS) for Pain	Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.	at 6, 12, 18, and 24 hours post procedure
Secondary	Time to First Dose of Narcotic Administration		up to 24 hours
Secondary	PACU Length of Stay	Post-Anesthesia Care Unit (PACU) length of stay (LOS)	average 24 hours
Secondary	Number of Participants With Pain by Location	Location of knee pain as anterior/posterior, medial/lateral	24 hours
Secondary	Ambulation Distance	Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT	Post-op Day 1
Secondary	Bartels Index	Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence.	Post-op Day 1