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

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Knee Osteoarthritis; Arthroplasty Complications; Postoperative Pain	Drug: Dexamethasone; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial
• Actual Study Start Date: September 29, 2023
• Estimated Primary Completion Date: July 1, 2024
• Estimated Study Completion Date: July 1, 2024

Arms and Interventions

Arm	Intervention/treatment
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.	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
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	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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

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

Locations

United States, Florida

University of Miami; Recruiting

Miami, Florida, United States, 33136

Contact: Joseph Costello, BS 305-243-4000 jpc251@med.miami.edu

Principal Investigator: Victor H Hernandez, MD

Sponsors and Collaborators

University of Miami

Investigators

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

More Information

• Responsible Party: Victor Hugo Hernandez, Professor of Clinical, University of Miami
• ClinicalTrials.gov Identifier: NCT05974501
• Other Study ID Numbers: 20230147
• First Posted: August 3, 2023
• Last Update Posted: October 3, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Pain, Postoperative; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Acetaminophen; Dexamethasone; Celecoxib; Meloxicam; Oxycodone; Ropivacaine; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anesthetics, Local; Anesthetics