iPACK Block With Dexamethasone For Total Knee Replacement

NCT04917055 | Terminated Phase 4 FDA Drug

• 1 other identifier: 210102
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

acute postoperative pain; knee replacement

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Gait Distance

  POD0-1 (first PT session)

• Knee Range of motion

  POD0-1 (first PT session)

• Length of stay

  Total number of days requiring hospitalization for surgical procedure. Up to 1 month

• Average Opioid Use postoperative day (POD) 1-2

  Postoperative day (POD) 1-2.

• Average Pain Score, postoperative day (POD) 1-2.

  Postoperative day (POD) 1-2.

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Adductor Canal Single Shot with long acting local anesthetic (ropivacaine) plus iPACK single shot with normal saline

Drug: Saline

Interventions

ropivacaine 0.25% with epinephrine and 6mg dexamethasone DRUG

Regional Nerve block behind the knee for posterior knee pain following total knee arthroplasty using ultrasound guidance, to be done distally between femoral chondyles

Active Treatment

Saline DRUG

Injection of Saline behind knee using ultrasound guidance

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Acute Pain; Pain, Postoperative

Interventions

Ropivacaine; Epinephrine; Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Engy Said, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Care provider and investigator will know if patient received SHAM or bupivacaine iPACK, but everyone else will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 8, 2021
• Study Start: June 7, 2021
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)