Clinical trial NCT03653416: Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Official title: Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteo Arthritis Knee
Keywords: Total knee arthroplasty
Peri articular infiltration
Pack block
Adductor canal catheter
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Narcotic Consumption
timeFrame: 24 hours
Secondary outcomes:
measure: Visual Analogue Score (VAS) for Pain
timeFrame: at 6, 12, 18, and 24 hours post procedure
measure: Time to First Dose of Narcotic Administration
timeFrame: up to 24 hours
measure: PACU Length of Stay
timeFrame: average 24 hours
measure: Number of Participants With Pain by Location
timeFrame: 24 hours
measure: Ambulation Distance
timeFrame: Post-op Day 1
measure: Bartels Index
timeFrame: Post-op Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Ichan School of Medicine
name: Yan H Lai, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.