iPACK Block With Dexamethasone For Total Knee Replacement

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

Tracking Information

• First Submitted Date: May 28, 2021
• First Posted Date: June 8, 2021
• Last Update Posted Date: June 9, 2022
• Actual Study Start Date: June 7, 2021
• Estimated Primary Completion Date: June 7, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: iPACK Block With Dexamethasone For Total Knee Replacement
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Knee Osteoarthritis
• Acute Pain
• Anesthesia, Local
• Regional Anesthesia

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 6, 2021): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 1, 2022
• Estimated Primary Completion Date: June 7, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04917055
• Other Study ID Numbers: 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

• 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: University of California, San Diego
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Engy Said, MD; University of California, San Diego

• PRS Account: University of California, San Diego
• Verification Date: June 2022