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Clinical Trials/NCT03703206
NCT03703206
Completed
Phase 3

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

University of Pennsylvania1 site in 1 country120 target enrollmentJuly 1, 2018

Overview

Phase
Phase 3
Intervention
ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)
Conditions
Knee Arthroplasty, Total
Sponsor
University of Pennsylvania
Enrollment
120
Locations
1
Primary Endpoint
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 1, 2018
End Date
August 27, 2021
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

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).

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

Outcomes

Primary Outcomes

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

  • 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 Sites (1)

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