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iPACK Block With Dexamethasone For Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT04917055
Recruitment Status : Not yet recruiting
First Posted : June 8, 2021
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Engy T. Said, MD, University of California, San Diego

Brief Summary:

Comparing the pain control outcomes for patients undergoing total knee arthroplasty (TKA) with either: 1) adductor canal single shot injection plus placebo iPACK injection or 2) adductor canal single shot injection plus bupivacaine and dexamethasone iPACK injection.

There are two surgical approaches for TKA 1) open 2) ROSA robotic assisted. Both follow the same pain management pathway. We plan to enroll patient undergoing either surgical procedure.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Acute Pain Anesthesia, Local Regional Anesthesia Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone Drug: Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Care provider and investigator will know if patient received SHAM or bupivacaine iPACK, but everyone else will be blinded
Primary Purpose: Treatment
Official Title: Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty
Estimated Study Start Date : June 7, 2021
Estimated Primary Completion Date : June 7, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Arm Intervention/treatment
Active Comparator: Active Treatment
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus distal iPACK (between femoral condyles) single shot with long acting local anesthetic (ropivacaine) plus dexamethasone
Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone
Regional Nerve block behind the knee for posterior knee pain following total knee arthroplasty using ultrasound guidance, to be done distally between femoral chondyles

Placebo Comparator: Placebo
Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline
Drug: Saline
Injection of Saline behind knee using ultrasound guidance




Primary Outcome Measures :
  1. Average Opioid Use POD 0-1 [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]
    Average Opioid Use

  2. Average Pain Score at Rest [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]
    Average Pain Score at Rest

  3. Average Pain Score with Motion [ Time Frame: Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement ]
    Average Pain Score with Motion


Secondary Outcome Measures :
  1. Gait Distance [ Time Frame: POD0-1 (first PT session) ]
    Distance patient can walk on with physical therapy (PT)

  2. Knee Range of motion [ Time Frame: POD0-1 (first PT session) ]
    Range of motion with Physical Therapy (PT)

  3. Length of stay [ Time Frame: Total number of days requiring hospitalization for surgical procedure. Up to 1 month ]
    From admission to hospital for surgery to discharge

  4. Average Opioid Use postoperative day (POD) 1-2 [ Time Frame: Postoperative day (POD) 1-2. ]
    Average Opioid Use in morphine equivalents

  5. Average Pain Score, postoperative day (POD) 1-2. [ Time Frame: Postoperative day (POD) 1-2. ]
    Average Pain Score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having total knee arthroplasty at UC San Diego
  • Plan to receive single shot adductor canal injection preoperatively
  • Plan to receive spinal anesthetic with or without sedation for TKA surgery

Exclusion Criteria:

  • Pregnancy
  • Inability to communicate with anesthesia provider and/or investigators
  • Severe renal, hepatic, cardiac disease
  • Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
  • BMI > 45 kg/m2
  • Allergy to study medications (lidocaine, bupivacaine)
  • Incarceration

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): NCT04917055


Contacts
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Contact: Engy Said, MD 6195436240 esaid@health.ucsd.edu

Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Engy Said, MD University of California, San Diego
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Responsible Party: Engy T. Said, MD, Clinical Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT04917055    
Other Study ID Numbers: 210102
First Posted: June 8, 2021    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Engy T. Said, MD, University of California, San Diego:
acute postoperative pain
knee replacement
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Acute Pain
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Pain
Neurologic Manifestations
Dexamethasone
Epinephrine
Ropivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents