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

NCT ID: NCT03703206

Last Updated: 2024-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-08-27

Brief Summary

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).

Conditions

Knee Arthroplasty, Total

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ACB + iPACK

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).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

nerve block for posterior knee pain after a TKA.

ACB w/o iPACK

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

nerve block for posterior knee pain after a TKA.

Intervention Type: DRUG

Other Intervention Names

iPACK

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Taras Grosh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

828618

Identifier Type: -

Identifier Source: org_study_id