Pre vs Post Block in Total Knee Arthroplasty (TKA)

• ClinicalTrials.gov Identifier: NCT05974501
• Recruitment Status: Recruiting
• First Posted: August 3, 2023
• Last Update Posted: October 3, 2023
• Sponsor: University of Miami
• Information provided by (Responsible Party): Victor Hugo Hernandez, University of Miami

Tracking Information

• First Submitted Date: July 26, 2023
• First Posted Date: August 3, 2023
• Last Update Posted Date: October 3, 2023
• Actual Study Start Date: September 29, 2023
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2023)

Change in pain status as measured by Numeric Pain Scale [ Time Frame: Baseline, up to 24 hours ]

Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 26, 2023)

• Number of patients reporting vomiting [ Time Frame: Up to 24 hours ]
  Count of patients reporting vomiting and number of episodes of vomiting
• Number of patients reporting nausea [ Time Frame: Up to 24 hours ]
  Count of patients reporting nausea and number of episodes of nausea
• Duration of hospital stay [ Time Frame: Up to 72 hours ]
  Count of time patient stays in hospital after surgery in hours
• Total opioid consumption in the immediate post-operative period [ Time Frame: Up to 24 hours ]
  Measure the amount of morphine milliequivalents consumed by patient

• 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: Pre vs Post Block in Total Knee Arthroplasty (TKA)
• Official Title: Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial
• Brief Summary: The purpose of this project is to determine if a change in patient reported pain, nausea and vomiting after total knee arthroplasty can be observed with the substitution of a post operative adductor canal block for a preoperative adductor canal block in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Supportive Care

Condition

• Knee Osteoarthritis
• Arthroplasty Complications
• Postoperative Pain

Intervention

• Drug: Dexamethasone
  Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
• Drug: Acetaminophen
  1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
• Drug: Lyrica
  Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
• Drug: Celebrex
  200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
• Drug: Meloxicam
  30mg administered via IV once postoperatively within 24 hours for pain and swelling
• Drug: Oxycodone
  5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
• Drug: Ropivacaine
  20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
  Other Name: Adductor Canal Block

Study Arms

• Active Comparator: 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.
  Interventions:

  • Drug: Dexamethasone
  • Drug: Acetaminophen
  • Drug: Lyrica
  • Drug: Celebrex
  • Drug: Meloxicam
  • Drug: Oxycodone
  • Drug: Ropivacaine
• Experimental: 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
  Interventions:

  • Drug: Dexamethasone
  • Drug: Acetaminophen
  • Drug: Lyrica
  • Drug: Celebrex
  • Drug: Meloxicam
  • Drug: Oxycodone
  • Drug: Ropivacaine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 26, 2023): 84
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 1, 2024
• Estimated Primary Completion Date: July 1, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1- Patients 18 or older 2 - Patients undergoing primary total knee replacement at the University of Miami Hospital 3 - Patients that have capacity to provide medical consent

Exclusion Criteria:

1. All patients under the age of 18
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.

Sex/Gender

• Sexes Eligible for Study: All

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

Contacts

Contact: Victor H. Hernandez, MD; 305-243-4000; vhh1@med.miami.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05974501
• Other Study ID Numbers: 20230147
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Victor Hugo Hernandez, University of Miami
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Victor H. Hernandez, MD; University of Miami

• PRS Account: University of Miami
• Verification Date: September 2023