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Clinical Trials/NCT05974501
NCT05974501
Completed
Phase 4

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

University of Miami1 site in 1 country84 target enrollmentSeptember 29, 2023

Overview

Phase
Phase 4
Intervention
Dexamethasone
Conditions
Knee Osteoarthritis
Sponsor
University of Miami
Enrollment
84
Locations
1
Primary Endpoint
Pain Status as Measured by Numeric Pain Scale
Status
Completed
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 29, 2023
End Date
January 22, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Victor Hugo Hernandez

Professor of Clinical

University of Miami

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

  • 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.

Arms & Interventions

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.

Intervention: Dexamethasone

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.

Intervention: Acetaminophen

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.

Intervention: Lyrica

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.

Intervention: Celebrex

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.

Intervention: Meloxicam

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.

Intervention: Oxycodone

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.

Intervention: Ropivacaine

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

Intervention: Dexamethasone

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

Intervention: Acetaminophen

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

Intervention: Lyrica

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

Intervention: Celebrex

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

Intervention: Meloxicam

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

Intervention: Oxycodone

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

Intervention: Ropivacaine

Outcomes

Primary Outcomes

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

  • Episodes of Nausea(24 hours postoperatively)
  • Episodes of Vomiting(24 hours postoperatively)
  • Discharges by Midnight on POD1(Up to 48 hours postoperatively)
  • Patients Reporting Nausea(24 hours postoperatively)
  • Hours Hospitalized(Up to 336 hours postoperatively)
  • Discharges by Midnight POD0(Up to 24 hours postoperatively)
  • Patients Reporting Vomiting(24 hours postoperatively)
  • Total Opioid Consumption(24 hours postoperatively)
  • Nights Hospitalized(Up to 14 nights postoperatively)

Study Sites (1)

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