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

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ClinicalTrials.gov Identifier: NCT03703206
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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).

Condition or disease Intervention/treatment Phase
Knee Arthroplasty, Total Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

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 Name: 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 second 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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703206


Contacts
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Contact: Nabil Elkassbany, MD 2158236700 nabil.elkassabany@uphs.upenn.edu
Contact: Aliaksei Basatski, BS 2156623772 Aliaksei.Basatski@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nabil Elkassabany, MD       nabil.elkassabany@uphs.upenn.edu   
Contact    2158236700      
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Taras Grosh, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03703206    
Other Study ID Numbers: 828618
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents