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Pre vs Post Block in Total Knee Arthroplasty (TKA)

Primary Purpose

Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Acetaminophen
Lyrica
Celebrex
Meloxicam
Oxycodone
Ropivacaine
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Preoperative Adductor Canal Block Group

Postoperative Adductor Canal Block Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in pain status as measured by Numeric Pain Scale
Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2023
Last Updated
September 30, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05974501
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Arthroplasty Complications, Postoperative Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Adductor Canal Block Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Postoperative Adductor Canal Block Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
Dexamethasone 10mg administered via IV once postoperatively within 24 hours for pain and swelling
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
1,000mg administered via tablet every 8 hours for pain during the first 1-2 weeks postoperatively
Intervention Type
Drug
Intervention Name(s)
Lyrica
Intervention Description
Administered via tablet 75mg nightly for pain during the first 1-2 weeks postoperatively
Intervention Type
Drug
Intervention Name(s)
Celebrex
Intervention Description
200mg administered via tablet twice a day for pain and swelling during the first 1-2 weeks postoperatively
Intervention Type
Drug
Intervention Name(s)
Meloxicam
Intervention Description
30mg administered via IV once postoperatively within 24 hours for pain and swelling
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
5mg administered via tablet every 4 hours as needed for pain during the first 1-2 weeks postoperatively
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Adductor Canal Block
Intervention Description
20 milliliters Ropivacaine 0.2% administered via injection perioperatively.
Primary Outcome Measure Information:
Title
Change in pain status as measured by Numeric Pain Scale
Description
Likert Scale with numeric scores ranging from 0 (least) to 10 (most) pain
Time Frame
Baseline, up to 24 hours
Secondary Outcome Measure Information:
Title
Number of patients reporting vomiting
Description
Count of patients reporting vomiting and number of episodes of vomiting
Time Frame
Up to 24 hours
Title
Number of patients reporting nausea
Description
Count of patients reporting nausea and number of episodes of nausea
Time Frame
Up to 24 hours
Title
Duration of hospital stay
Description
Count of time patient stays in hospital after surgery in hours
Time Frame
Up to 72 hours
Title
Total opioid consumption in the immediate post-operative period
Description
Measure the amount of morphine milliequivalents consumed by patient
Time Frame
Up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor H. Hernandez, MD
Phone
305-243-4000
Email
vhh1@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor H. Hernandez, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Costello, BS
Phone
305-243-4000
Email
jpc251@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Victor H Hernandez, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pre vs Post Block in Total Knee Arthroplasty (TKA)

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