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

University of Pennsylvania120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Knee Arthroplasty, Total

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: Six hours after surgery

Secondary Outcomes

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.

Time frame: 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).

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

Data from ClinicalTrials.gov

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