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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03703206
Other study ID # 828618
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date July 1, 2018
Est. completion date August 27, 2021

Study information

Verified date May 2024
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 27, 2021
Est. primary completion date August 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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