Pre vs Post Block in Total Knee Arthroplasty (TKA)

Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Knee Osteoarthritis; Arthroplasty Complications
• Intervention / Treatment: Drug: Dexamethasone; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Adductor Canal Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Status as Measured by Numeric Pain Scale	Scale with numeric scores ranging from 0 (least) to 10 (most) pain	2 hours postoperatively
Pain Status as Measured by Numeric Pain Scale	Scale with numeric scores ranging from 0 (least) to 10 (most) pain	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients Reporting Nausea	Count of the number of patients reporting nausea	2 hours postoperatively
Episodes of Nausea	Count of the number of episodes of nausea per patient	2 hours postoperatively
Patients Reporting Nausea	Count of the number of patients reporting nausea	24 hours postoperatively
Episodes of Nausea	Count of the number of episodes of nausea per patient	24 hours postoperatively
Patients Reporting Vomiting	Count of the number of patients reporting vomiting	2 hours postoperatively
Episodes of Vomiting	Count of the number of episodes of vomiting per patient	2 hours postoperatively
Patients Reporting Vomiting	Count of the number of patients reporting vomiting	24 hours postoperatively
Episodes of Vomiting	Count of the number of episodes of vomiting per patient	24 hours postoperatively
Total Opioid Consumption	Measure of the amount of morphine milliequivalents consumed by the patient	2 hours postoperatively
Total Opioid Consumption	Measure of the amount of morphine milliequivalents consumed by the patient	24 hours postoperatively
Nights Hospitalized	Number of nights hospitalized	Up to 14 nights postoperatively
Hours Hospitalized	Number of hours hospitalized	Up to 336 hours postoperatively
Discharges by Midnight POD0	The number of patients discharged home by midnight on postoperative day zero	Up to 24 hours postoperatively
Discharges by Midnight on POD1	The number of patients discharged home by midnight postoperative day one	Up to 48 hours postoperatively

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): January 22, 2024

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: July 26, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Pain, Postoperative; Osteoarthritis; Osteoarthritis, Knee; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Antirheumatic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib; Ropivacaine; Meloxicam; Dexamethasone; Acetaminophen; Oxycodone
• Other Study ID Numbers: 20230147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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