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OpenTrials
Completed

NCT Number: NCT05974501

Pre vs Post Block in Total Knee Arthroplasty (TKA)

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Dexamethasone

Drug

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

Acetaminophen

Drug

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

lyrica

Drug

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

Celebrex

Drug

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

Meloxicam

Drug

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

Oxycodone

Drug

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

Ropivacaine

Drug

20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Other names: Adductor Canal Block

Primary outcomes

  1. Pain Status as Measured by Numeric Pain Scale

    Time frame: 2 hours postoperatively

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

  2. Pain Status as Measured by Numeric Pain Scale

    Time frame: 24 hours postoperatively

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

Secondary outcomes

  1. Patients Reporting Nausea

    Time frame: 2 hours postoperatively

    Count of the number of patients reporting nausea

  2. Episodes of Nausea

    Time frame: 2 hours postoperatively

    Count of the number of episodes of nausea per patient

  3. Patients Reporting Nausea

    Time frame: 24 hours postoperatively

    Count of the number of patients reporting nausea

  4. Episodes of Nausea

    Time frame: 24 hours postoperatively

    Count of the number of episodes of nausea per patient

  5. Patients Reporting Vomiting

    Time frame: 2 hours postoperatively

    Count of the number of patients reporting vomiting

  6. Episodes of Vomiting

    Time frame: 2 hours postoperatively

    Count of the number of episodes of vomiting per patient

  7. Patients Reporting Vomiting

    Time frame: 24 hours postoperatively

    Count of the number of patients reporting vomiting

  8. Episodes of Vomiting

    Time frame: 24 hours postoperatively

    Count of the number of episodes of vomiting per patient

  9. Total Opioid Consumption

    Time frame: 2 hours postoperatively

    Measure of the amount of morphine milliequivalents consumed by the patient

  10. Total Opioid Consumption

    Time frame: 24 hours postoperatively

    Measure of the amount of morphine milliequivalents consumed by the patient

  11. Nights Hospitalized

    Time frame: Up to 14 nights postoperatively

    Number of nights hospitalized

  12. Hours Hospitalized

    Time frame: Up to 336 hours postoperatively

    Number of hours hospitalized

  13. Discharges by Midnight POD0

    Time frame: Up to 24 hours postoperatively

    The number of patients discharged home by midnight on postoperative day zero

  14. Discharges by Midnight on POD1

    Time frame: Up to 48 hours postoperatively

    The number of patients discharged home by midnight postoperative day one

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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