Pre vs Post Block in Total Knee Arthroplasty (TKA)

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05974501
• Other study ID #: 20230147
• Status: Recruiting
• Phase: Phase 4
• Start date: September 29, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Victor H. Hernandez, MD
• Phone: 305-243-4000
• Email: vhh1[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty Complications
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
• Acetaminophen
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
• Lyrica
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
• Celebrex
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
• Meloxicam
30mg administered via IV once postoperatively within 24 hours for pain and swelling
• Oxycodone
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
• Ropivacaine
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain status as measured by Numeric Pain Scale	Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain	Baseline, up to 24 hours
Secondary	Number of patients reporting vomiting	Count of patients reporting vomiting and number of episodes of vomiting	Up to 24 hours
Secondary	Number of patients reporting nausea	Count of patients reporting nausea and number of episodes of nausea	Up to 24 hours
Secondary	Duration of hospital stay	Count of time patient stays in hospital after surgery in hours	Up to 72 hours
Secondary	Total opioid consumption in the immediate post-operative period	Measure the amount of morphine milliequivalents consumed by patient	Up to 24 hours