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Nerve Block for Knee Surgery Pain Control
Phase 2 & 3
Waitlist Available
Led By Bryan D Springer, MD
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients age 30-85 undergoing first-time primary unilateral total knee arthroplasty for osteoarthritis and remaining hospitalized for at least one night
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
Awards & highlights
Study Summary
This trial will help determine if a nerve block in addition to a cocktail of pain medications can help control pain better for patients undergoing knee surgery.
Who is the study for?
This trial is for individuals aged 30-85 who are having their first total knee replacement due to osteoarthritis and will stay in the hospital overnight. It's not for those who have taken opioids before surgery, need a revision or bilateral knee replacement, have post-traumatic or inflammatory arthritis, previous surgeries on that knee, same-day discharge plans, contralateral knee replacements, or a history of substance abuse.Check my eligibility
What is being tested?
The study is testing if adding an adductor canal block with ropivacaine (a numbing medication) to standard pain relief methods provides better pain control after knee replacement surgery than using saline (a placebo). Patients receive either the real drug or saline alongside regular pain management.See study design
What are the potential side effects?
Ropivacaine can cause side effects like nausea, vomiting, low blood pressure, dizziness, headaches and in rare cases nerve damage. Saline injections typically don't cause side effects but may include discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 30-85 years old and having my first knee replacement due to arthritis, staying in the hospital overnight.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 6 hours for postoperative day 0-2, every 6 hours on postoperative day 4, and at 4-6 week visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative pain, as defined by patient-reported NPRS pain scores on a scale of 0-10 on Postoperative day 1
Secondary outcome measures
Gait Assessment
Pain
Patient Satisfaction with Pain
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment Group (Ropivacaine)Experimental Treatment2 Interventions
The treatment group will consist of patients undergoing total knee arthroplasty who receive standardized 100 cc periarticularinjection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients will then receive 10cc of ropivacaineinto their adductor canal.This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.
Group II: Control Group (Saline)Placebo Group2 Interventions
The control group will consist of patients undergoing total knee arthroplasty who receive a standardized periarticular injection into the lateral femoral periosteum, posterior capsule, medial periosteum, capsule and skin. Patients randomized in this group will then receive 10cc of saline into their adductor canal. This will be administered by injecting into the adductor canal without dissecting down to the saphenous nerve and without ultrasound guidance.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Total Knee Arthroplasty
2017
Completed Phase 4
~1180
Ropivacaine injection
2012
Completed Phase 4
~510
Find a Location
Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
34 Previous Clinical Trials
5,801 Total Patients Enrolled
Towson Orthopaedic AssociatesOTHER
1 Previous Clinical Trials
160 Total Patients Enrolled
Bryan D Springer, MDPrincipal InvestigatorOrthoCarolina Research Institute, Inc.
2 Previous Clinical Trials
320 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have inflammatory arthritis.I am between 30-85 years old and having my first knee replacement due to arthritis, staying in the hospital overnight.I am having knee replacement surgery and will go home the same day.I have had surgery that opened my knee joint before.I am having surgery to replace both of my knees.I am having knee replacement surgery due to arthritis from an injury.I am having a second surgery to replace my knee joint.I have had knee replacement surgery on my other knee.I have been taking opioids before my knee replacement surgery.You have a history of using drugs or alcohol excessively.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group (Saline)
- Group 2: Treatment Group (Ropivacaine)
Awards:
This trial has 0 awards, including: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.
Why do most people get Total Knee Arthroplasty?
"Total Knee Arthroplasty is used to treat various conditions that cause pain, including surgical anesthesia, labour, and postoperative pain."
Answered by AI
Do octogenarians qualify for this clinical research?
"The required age range for this clinical trial is between 30 and 85 years old."
Answered by AI
What is the treatment size for this clinical trial?
"This study is no longer recruiting patients. The clinical trial was posted on October 9th 2020 and was edited for the last time on March 31st 2022. If you are looking for other studies, 661 different trials for arthrosis and 73 for Total Knee Arthroplasty are currently recruiting."
Answered by AI
Are there any other research projects currently underway that are similar to this Total Knee Arthroplasty study?
"The first study on Total Knee Arthroplasty was completed in 2012 at Azienda Ospedaliera-Università Padova. As of now, there have been a total of 433 studies with 73 of them being active. A large number of these active studies are located in Towson, Maryland."
Answered by AI
Are people with the required qualifications currently able to participate in this clinical trial?
"This particular clinical trial is not looking for any more participants at this time. The study was initially posted on October 9th, 2020 and was last edited on March 31st, 2022. For those still seeking to enroll in a clinical trial, there are 661 active studies for arthrosis and 73 for Total Knee Arthroplasty."
Answered by AI
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