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

The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty

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).

Study Overview

• Status: Completed
• Conditions: Knee Arthroplasty, Total
• Intervention / Treatment: Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: 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.; Other Names: iPACK
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score Measurement Reported by Patients	Average of pain scores over the first 24 hours following the regional anesthetic based on Numeric Rating Scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible.	24 hours after surgery
Quality of Recovery (QoR) Score	Score of QoR-15 survey to determine recovery status. The questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts. Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). The 2nd part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). The total score is obtained by adding the scores of all the 15 questions. The total score is 0 (poor_ to 150 (excellent).	one week, measurements are obtained at 24 hours, 48 hours, and one week

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Taras Grosh, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): August 27, 2021

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): May 30, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: 828618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes