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Completed

NCT Number: NCT03703206

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

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).

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Key information

Conditions

Knee Arthroplasty, Total

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: iPACK

Primary outcomes

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

    Time frame: Six 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

Secondary outcomes

  1. Pain Score Measurement Reported by Patients

    Time frame: 24 hours after surgery

    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.

  2. Quality of Recovery (QoR) Score

    Time frame: one week, measurements are obtained at 24 hours, 48 hours, and one week

    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).

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 11, 2018
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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