Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
84 participants
INTERVENTIONAL
2023-09-29
2024-01-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Preoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management for TKA including a preoperative adductor canal block. Participants will be in this group for up to 24 hours after surgery.
Dexamethasone
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Acetaminophen
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Lyrica
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Celebrex
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Meloxicam
30mg administered via IV once postoperatively within 24 hours for pain and swelling
Oxycodone
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Ropivacaine
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
Postoperative Adductor Canal Block Group
Participants in this group will receive the standard of care treatment for pain management after TKA, however, the adductor canal block will be placed postoperatively. Participants will be in this group for up to 24 hours
Dexamethasone
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Acetaminophen
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Lyrica
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Celebrex
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Meloxicam
30mg administered via IV once postoperatively within 24 hours for pain and swelling
Oxycodone
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Ropivacaine
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
Interventions
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Dexamethasone
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Acetaminophen
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Lyrica
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Celebrex
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Meloxicam
30mg administered via IV once postoperatively within 24 hours for pain and swelling
Oxycodone
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Ropivacaine
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Prisoners, uncontrolled diabetics, increased risk of bleeding, pregnant women, women planning on becoming pregnant in the next year, and women who think they might be pregnant.
3. Patients with prior surgery or history of infection on the joint of interest.
4. Patients on steroid preoperatively.
5. Inability to provide medical consent.
6. Patients with a history of significant unmitigated pain in parts of their body not including the knee the procedure is to be performed or a history of pain catastrophizing (the tendency to magnify the threat value of the pain stimulus and to feel helpless in the context of pain, and by a relative inability to inhibit pain-related thoughts in anticipation of, during or following a painful event) regarding pain anywhere in the body.
7. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.
8. Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Victor Hugo Hernandez
Professor of Clinical
Principal Investigators
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Victor H. Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20230147
Identifier Type: -
Identifier Source: org_study_id
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