MedPath

Pre vs Post Block in Total Knee Arthroplasty (TKA)

Phase 4
Completed
Conditions
Knee Osteoarthritis
Arthroplasty Complications
Postoperative Pain
Interventions
Registration Number
NCT05974501
Lead Sponsor
University of Miami
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
84
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Preoperative Adductor Canal Block GroupDexamethasoneParticipants 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.
Preoperative Adductor Canal Block GroupAcetaminophenParticipants 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.
Preoperative Adductor Canal Block GroupLyricaParticipants 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.
Postoperative Adductor Canal Block GroupDexamethasoneParticipants 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
Postoperative Adductor Canal Block GroupAcetaminophenParticipants 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
Postoperative Adductor Canal Block GroupLyricaParticipants 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
Postoperative Adductor Canal Block GroupMeloxicamParticipants 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
Preoperative Adductor Canal Block GroupCelebrexParticipants 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.
Preoperative Adductor Canal Block GroupMeloxicamParticipants 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.
Preoperative Adductor Canal Block GroupOxycodoneParticipants 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.
Preoperative Adductor Canal Block GroupRopivacaineParticipants 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.
Postoperative Adductor Canal Block GroupRopivacaineParticipants 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
Postoperative Adductor Canal Block GroupCelebrexParticipants 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
Postoperative Adductor Canal Block GroupOxycodoneParticipants 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
Primary Outcome Measures
NameTimeMethod
Pain Status as Measured by Numeric Pain Scale24 hours postoperatively

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

Secondary Outcome Measures
NameTimeMethod
Episodes of Nausea24 hours postoperatively

Count of the number of episodes of nausea per patient

Episodes of Vomiting24 hours postoperatively

Count of the number of episodes of vomiting per patient

Discharges by Midnight on POD1Up to 48 hours postoperatively

The number of patients discharged home by midnight postoperative day one

Patients Reporting Nausea24 hours postoperatively

Count of the number of patients reporting nausea

Hours HospitalizedUp to 336 hours postoperatively

Number of hours hospitalized

Discharges by Midnight POD0Up to 24 hours postoperatively

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

Patients Reporting Vomiting24 hours postoperatively

Count of the number of patients reporting vomiting

Total Opioid Consumption24 hours postoperatively

Measure of the amount of morphine milliequivalents consumed by the patient

Nights HospitalizedUp to 14 nights postoperatively

Number of nights hospitalized

Trial Locations

Locations (1)

University of Miami

🇺🇸

Miami, Florida, United States

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