The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)

University of Pennsylvania

Status and phase: Completed; Phase 3

Conditions: Knee Arthroplasty, Total

Treatments: Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)

Study type: Interventional

Funder types: Other

Identifiers

NCT03703206

828618

Details and patient eligibility

About

This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).

Enrollment: 120 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients scheduled for total knee arthroplasty
• American Society Anesthesiologists (ASA) physical status I- III.
• Mentally competent and able to give consent for enrollment in the study.

Exclusion criteria

• Patient refusal,
• allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
• Revision surgery will be excluded.
• Impaired kidney functions
• patient with coagulopathy will be also excluded.
• Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
• BMI of 45 or more

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups

ACB + iPACK

Experimental group

Description:

Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK).

Treatment:

Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)

ACB w/o iPACK

No Intervention group

Description:

Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty.