iPACK Block With Dexamethasone For Total Knee Replacement

Impact of Adding iPACK Block With Dexamethasone to Existing APS Multimodal Analgesia Protocol for Patients Undergoing Total Knee Arthroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Knee Osteoarthritis; Anesthesia, Local; Acute Pain; Regional Anesthesia
• Intervention / Treatment: Drug: ropivacaine 0.25% with epinephrine and 6mg dexamethasone; Drug: Saline

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
• Enrollment (Actual): 14
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Opioid Use POD 0-1	Average Opioid Use	Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement
Average Pain Score at Rest	Average Pain Score at Rest	Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement
Average Pain Score with Motion	Average Pain Score with Motion	Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait Distance	Distance patient can walk on with physical therapy (PT)	POD0-1 (first PT session)
Knee Range of motion	Range of motion with Physical Therapy (PT)	POD0-1 (first PT session)
Length of stay	From admission to hospital for surgery to discharge	Total number of days requiring hospitalization for surgical procedure. Up to 1 month
Average Opioid Use postoperative day (POD) 1-2	Average Opioid Use in morphine equivalents	Postoperative day (POD) 1-2.
Average Pain Score, postoperative day (POD) 1-2.	Average Pain Score	Postoperative day (POD) 1-2.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): June 7, 2022

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 6, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: acute postoperative pain; knee replacement
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Dexamethasone; Ropivacaine; Epinephrine
• Other Study ID Numbers: 210102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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