Clinical trial NCT05974501: Pre vs Post Block in Total Knee Arthroplasty (TKA)
Official title: Pre vs. Postoperative Adductor Canal Block for Total Knee Arthroplasty: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Arthroplasty Complications
Postoperative Pain
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2023-08-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


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:

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.

Primary outcomes:
measure: Pain Status as Measured by Numeric Pain Scale
timeFrame: 2 hours postoperatively
measure: Pain Status as Measured by Numeric Pain Scale
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Patients Reporting Nausea
timeFrame: 2 hours postoperatively
measure: Episodes of Nausea
timeFrame: 2 hours postoperatively
measure: Patients Reporting Nausea
timeFrame: 24 hours postoperatively
measure: Episodes of Nausea
timeFrame: 24 hours postoperatively
measure: Patients Reporting Vomiting
timeFrame: 2 hours postoperatively
measure: Episodes of Vomiting
timeFrame: 2 hours postoperatively
measure: Patients Reporting Vomiting
timeFrame: 24 hours postoperatively
measure: Episodes of Vomiting
timeFrame: 24 hours postoperatively
measure: Total Opioid Consumption
timeFrame: 2 hours postoperatively
measure: Total Opioid Consumption
timeFrame: 24 hours postoperatively
measure: Nights Hospitalized
timeFrame: Up to 14 nights postoperatively
measure: Hours Hospitalized
timeFrame: Up to 336 hours postoperatively
measure: Discharges by Midnight POD0
timeFrame: Up to 24 hours postoperatively
measure: Discharges by Midnight on POD1
timeFrame: Up to 48 hours postoperatively
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Victor H. Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References: