iPACK Block With Dexamethasone For Total Knee Replacement

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04917055
• Other study ID #: 210102
• Status: Terminated
• Phase: Phase 4
• Start date: June 7, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anesthesia, Local
• Knee Osteoarthritis
• 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
• Saline
Injection of Saline behind knee using ultrasound guidance

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Opioid Use POD 0-1	Average Opioid Use	Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement
Primary	Average Pain Score at Rest	Average Pain Score at Rest	Postoperative day (POD) 0-1, as defined by 24 hours after iPACK block placement
Primary	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	Gait Distance	Distance patient can walk on with physical therapy (PT)	POD0-1 (first PT session)
Secondary	Knee Range of motion	Range of motion with Physical Therapy (PT)	POD0-1 (first PT session)
Secondary	Length of stay	From admission to hospital for surgery to discharge	Total number of days requiring hospitalization for surgical procedure. Up to 1 month
Secondary	Average Opioid Use postoperative day (POD) 1-2	Average Opioid Use in morphine equivalents	Postoperative day (POD) 1-2.
Secondary	Average Pain Score, postoperative day (POD) 1-2.	Average Pain Score	Postoperative day (POD) 1-2.