Pre vs Post Block in Total Knee Arthroplasty (TKA)

Sponsor

University of Miami (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05974501

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis Arthroplasty Complications Postoperative Pain	Drug: Dexamethasone Drug: Acetaminophen Drug: Lyrica Drug: Celebrex Drug: Meloxicam Drug: Oxycodone Drug: Ropivacaine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Dexamethasone

Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling

Drug: Acetaminophen

1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively

Drug: Lyrica

Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively

Drug: Celebrex

200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively

Drug: Meloxicam

30mg administered via IV once postoperatively within 24 hours for pain and swelling

Drug: Oxycodone

5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively

Drug: Ropivacaine

20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Other Names:

Adductor Canal Block

Experimental: 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

Drug: Dexamethasone

Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling

Drug: Acetaminophen

1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively

Drug: Lyrica

Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively

Drug: Celebrex

200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively

Drug: Meloxicam

30mg administered via IV once postoperatively within 24 hours for pain and swelling

Drug: Oxycodone

5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively

Drug: Ropivacaine

20 milliliters Ropivacaine 0.2% administered via injection perioperatively.

Other Names:

Adductor Canal Block

Outcome Measures

Primary Outcome Measures

Change in pain status as measured by Numeric Pain Scale [Baseline, up to 24 hours]
Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain

Secondary Outcome Measures

Number of patients reporting vomiting [Up to 24 hours]
Count of patients reporting vomiting and number of episodes of vomiting
Number of patients reporting nausea [Up to 24 hours]
Count of patients reporting nausea and number of episodes of nausea
Duration of hospital stay [Up to 72 hours]
Count of time patient stays in hospital after surgery in hours
Total opioid consumption in the immediate post-operative period [Up to 24 hours]
Measure the amount of morphine milliequivalents consumed by patient

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.