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iPACK Block With Dexamethasone For Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT04917055
Recruitment Status : Recruiting
First Posted : June 8, 2021
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
Engy T. Said, MD, University of California, San Diego

Tracking Information
First Submitted Date  ICMJE May 28, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 9, 2022
Actual Study Start Date  ICMJE June 7, 2021
Estimated Primary Completion Date June 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2021)
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2021)
  • Gait Distance [ Time Frame: POD0-1 (first PT session) ]
    Distance patient can walk on with physical therapy (PT)
  • Knee Range of motion [ Time Frame: POD0-1 (first PT session) ]
    Range of motion with Physical Therapy (PT)
  • 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
  • Average Opioid Use postoperative day (POD) 1-2 [ Time Frame: Postoperative day (POD) 1-2. ]
    Average Opioid Use in morphine equivalents
  • Average Pain Score, postoperative day (POD) 1-2. [ Time Frame: Postoperative day (POD) 1-2. ]
    Average Pain Score
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE iPACK Block With Dexamethasone For Total Knee Replacement
Official Title  ICMJE Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty
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.

Detailed Description

This will be a single-center (UCSD), randomized blinded investigation.

Enrollment. Consenting adults undergoing TKA will be offered enrollment. Study inclusion will be proposed to eligible patients prior to surgery. If a patient desires study participation, written, informed consent will be obtained using a current UCSD IRB-approved ICF.

Preoperative Procedures. Following written, informed consent, we will record baseline anthropomorphic information (age, sex, height, and weight) that is already provided by all patients having surgery. After consenting and prior to surgery, patients will be randomized (utilizing sealed envelopes with 1:1 ratio) to either single-shot adductor canal block with sham iPACK block or single-shot adductor canal block with local anesthetic + dexamethasone iPACK block. A regional anesthesia fellow, not participating in the study, will open the sealed envelope and prepare the iPACK solution to be used accordingly.

Current Standard Care: Currently, all patients undergoing TKA receive preoperative adductor canal block as well as multimodal pain regimen managed by APS. They all receive intraoperative intraarticular injections by the surgical team. Spinal vs general anesthesia is decided at the discretion of the intraoperative anesthesiologist along with patient preferences and relevant contraindications. The only difference for subjects participating in the study (vs those not participating) will be that they will be randomized to receive an additional nerve block for posterior knee pain.

Adductor canal single shot block + Sham group: In the preoperative holding area, all subjects in this cohort will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine. Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step, Medi-Flex Hospital Products, Inc., Overland Park, KS, USA). A single shot adductor canal block will be performed under ultrasound guidance with 20 mls of 0.25% ropivacaine with 1:400,000 epinephrine. A sensory level to ice will be confirmed and decided to be adequate if positive based on the discretion of the attending anesthesiologist. A Sham iPACK block will then be performed under ultrasound guidance, where 20 mls of 0.9% normal saline with 1:400,000 epi (as a vascular marker) is injected between the popliteal artery and the posterior aspect of the femoral condyle. As is standard for all TKA at our institution, all patients will additionally receive an intraoperative intraarticular injection by the surgical team of 50 mls 0.25% bupivacaine + 30 mg Ketorolac + 0.25mg epinephrine, which will occur at least 60 minutes after preoperative perineural injections.

Adductor canal single shot block + iPACK group: In the preoperative holding area, all subjects in this cohort will have a peripheral intravenous (IV) catheter inserted, standard noninvasive monitors applied, supplemental oxygen administered via a nasal cannula or face mask, and positioned supine. Midazolam and fentanyl (IV) will be titrated for patient comfort, while ensuring that patients remain responsive to verbal cues. The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol (ChloraPrep One-Step, Medi-Flex Hospital Products, Inc., Overland Park, KS, USA). A single shot adductor canal block will be performed under ultrasound guidance with 20 mls of 0.25% ropivacaine with 1:400,000 epinephrine. A sensory level to ice will be confirmed and decided to be adequate if positive based on the discretion of the attending anesthesiologist. An iPACK block will then be performed under ultrasound guidance, where 20 mls of 0.25% ropivacaine with 1:400,000 epinephrine and 6mg dexamethasone is injected between the popliteal artery and the posterior aspect of the femoral condyle. As is standard for all TKA at our institution, all patients will additionally receive an intraoperative intraarticular injection by the surgical team of 50 mls 0.25% bupivacaine + 30 mg Ketorolac + 0.25mg epinephrine, which will occur at least 60 minutes after preoperative perineural injections.

Additional Postoperative Pain Interventions: Intraoperatively, spinal anesthesia versus general anesthesia will be decided at the discretion of the operating room anesthesiologist. Postoperatively, both groups will be started on the same multimodal oral regimen and followed by our anesthesiology led acute pain team.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Knee Osteoarthritis
  • Acute Pain
  • Anesthesia, Local
  • Regional Anesthesia
Intervention  ICMJE
  • 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
  • Drug: Saline
    Injection of Saline behind knee using ultrasound guidance
Study Arms  ICMJE
  • 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
    Intervention: Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone
  • Placebo Comparator: Placebo
    Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline
    Intervention: Drug: Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2021)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2022
Estimated Primary Completion Date June 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Engy Said, MD 6195436240 esaid@health.ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04917055
Other Study ID Numbers  ICMJE 210102
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Engy T. Said, MD, University of California, San Diego
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Diego
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Engy Said, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP