Phase 4
N=84
Pre vs Post Block in Total Knee Arthroplasty (TKA)
Knee Osteoarthritis · Arthroplasty Complications · Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT05974501 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Pain Status as Measured by Numeric Pain Scale — 2; 4.00 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dexamethasone (Drug); Acetaminophen (Drug); Lyrica (Drug); Celebrex (Drug); Meloxicam (Drug); Oxycodone (Drug); Ropivacaine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Status as Measured by Numeric Pain Scale |
6.00; 6.00 | — |
| PRIMARY Pain Status as Measured by Numeric Pain Scale |
6.00; 6.00 | — |
| SECONDARY Patients Reporting Nausea |
8; 5 | — |
| SECONDARY Episodes of Nausea |
0.00; 0.00 | — |
| SECONDARY Patients Reporting Nausea |
8; 5 | — |
| SECONDARY Episodes of Nausea |
0.00; 0.00 | — |
| SECONDARY Patients Reporting Vomiting |
3; 2 | — |
| SECONDARY Episodes of Vomiting |
0.00; 0.00 | — |
| SECONDARY Patients Reporting Vomiting |
3; 2 | — |
| SECONDARY Episodes of Vomiting |
0.00; 0.00 | — |
| SECONDARY Total Opioid Consumption |
45.00; 36.00 | — |
| SECONDARY Total Opioid Consumption |
45.00; 36.00 | — |
| SECONDARY Nights Hospitalized |
1.00; 1.00 | — |
| SECONDARY Hours Hospitalized |
23.66; 25.92 | — |
| SECONDARY Discharges by Midnight POD0 |
3; 4 | — |
| SECONDARY Discharges by Midnight on POD1 |
40; 29 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT05974501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.