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Procedure
Preoperative Nerve Block for Knee Replacement Surgery
Phase 4
Recruiting
Led By Victor H. Hernandez, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing primary total knee replacement at the University of Miami Hospital
Patients that have capacity to provide medical consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours
Awards & highlights
Study Summary
This trial will study if using a nerve block before knee surgery can reduce pain, nausea, and vomiting and lower opioid use.
Who is the study for?
This trial is for adults over 18 who are having their first knee replacement at the University of Miami Hospital. They must be able to give medical consent and not have allergies to local anesthetics or medications used in joint replacement protocols, uncontrolled diabetes, high bleeding risk, or a history of surgery/infection on the affected joint.Check my eligibility
What is being tested?
The study aims to see if switching from a preoperative adductor canal block to a postoperative one in knee surgery affects patient pain levels, nausea/vomiting, and reduces opioid use. It involves various drugs like Ropivacaine and Oxycodone as part of the pain management protocol.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, nausea, vomiting due to anesthesia or opioids; dizziness and sleepiness from Lyrica; increased bleeding risk with Celebrex/Meloxicam; liver damage risks with Acetaminophen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having a total knee replacement at the University of Miami Hospital.
Select...
I am able to understand and agree to the treatment plan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain status as measured by Numeric Pain Scale
Secondary outcome measures
Duration of hospital stay
Number of patients reporting nausea
Number of patients reporting vomiting
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Postoperative Adductor Canal Block GroupExperimental Treatment7 Interventions
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
Group II: Preoperative Adductor Canal Block GroupActive Control7 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ropivacaine
2017
Completed Phase 4
~1960
Acetaminophen
2017
Completed Phase 4
~2030
Dexamethasone
2007
Completed Phase 4
~2590
Lyrica
2016
Completed Phase 3
~570
Meloxicam
2014
Completed Phase 4
~48770
Oxycodone
2014
Completed Phase 4
~2210
Celebrex
2018
Completed Phase 4
~2700
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,992 Total Patients Enrolled
Victor H. Hernandez, MDPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had severe pain not related to my knee or tend to feel extremely anxious about pain.I am having a total knee replacement at the University of Miami Hospital.I think I might be pregnant.I have had surgery or an infection in the joint we are looking at.I am taking steroids before surgery.I am at a higher risk of bleeding.I am unable to give consent for medical procedures.I am younger than 18 years old.I am allergic to local anesthetics or medications used in joint replacement.My diabetes is not under control.I am 18 years old or older.I am able to understand and agree to the treatment plan.
Research Study Groups:
This trial has the following groups:- Group 1: Postoperative Adductor Canal Block Group
- Group 2: Preoperative Adductor Canal Block Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Postoperative Adductor Canal Block Group been given regulatory acceptance by the FDA?
"There is a wealth of evidence supporting the safety of Postoperative Adductor Canal Block Group, thus it received an evaluation score of three."
Answered by AI
Is the enrollment period open for this investigation?
"Clinicaltrials.gov provides evidence that this clinical trial is not recruiting at the present moment. It was initially published on October 1st 2023, and last updated July 26th 2023. Nevertheless, 1199 other studies currently have open enrollment periods for prospective study participants."
Answered by AI
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