Pre vs Post Block in Total Knee Arthroplasty (TKA)

NCT05974501 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 20230147
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis; Arthroplasty Complications; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Patients Reporting Nausea

  2 hours postoperatively

• Episodes of Nausea

  2 hours postoperatively

• Patients Reporting Nausea

  24 hours postoperatively

• Episodes of Nausea

  24 hours postoperatively

• Patients Reporting Vomiting

  2 hours postoperatively

Study Arms (2)

Preoperative Adductor Canal Block Group

ACTIVE COMPARATOR

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; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine

Postoperative Adductor Canal Block Group

EXPERIMENTAL

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; Drug: Acetaminophen; Drug: Lyrica; Drug: Celebrex; Drug: Meloxicam; Drug: Oxycodone; Drug: Ropivacaine

Interventions

Dexamethasone DRUG

Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Acetaminophen DRUG

1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Lyrica DRUG

Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Celebrex DRUG

200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Meloxicam DRUG

30mg administered via IV once postoperatively within 24 hours for pain and swelling

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Oxycodone DRUG

5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Ropivacaine DRUG

20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Also known as: Adductor Canal Block

Postoperative Adductor Canal Block Group; Preoperative Adductor Canal Block Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• All patients under the age of 18
• 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.
• Patients with prior surgery or history of infection on the joint of interest.
• Patients on steroid preoperatively.
• Inability to provide medical consent.
• 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.
• 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.
• Allergy to local anesthetic or any medication used in the standard protocol for joint replacement.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain, Postoperative

Interventions

Dexamethasone; Acetaminophen; Pregabalin; Celecoxib; Meloxicam; Oxycodone; Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazines; Thiazoles; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Results Point of Contact

• Title: Dr. Victor H. Hernandez
• Organization: University of Miami

vhh1@med.miami.edu

305-243-4000

Study Officials

• Victor H. Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 3, 2023
• Study Start: September 29, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)