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

NCT03703206 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 828618
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery

  Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator

  Six hours after surgery

Secondary Outcomes (2)

• Pain Score Measurement Reported by Patients

  24 hours after surgery

• Quality of Recovery (QoR) Score

  one week, measurements are obtained at 24 hours, 48 hours, and one week

Study Arms (2)

ACB + iPACK

EXPERIMENTAL

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).

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

ACB w/o iPACK

NO INTERVENTION

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

Interventions

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

nerve block for posterior knee pain after a TKA.

Also known as: iPACK

ACB + iPACK

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Nabil Elkassbany, MD
• Organization: University of Pennsylvania

nabil.elkassabany@uphs.upenn.edu

2158236700

Study Officials

• Taras Grosh, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: October 11, 2018
• Study Start: July 1, 2018
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2021
• Last Updated: May 30, 2024
• Results First Posted: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)