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General vs Spinal Anesthesia for Osteoarthritis
Miami, FL
N/A
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
Subjects must be capable of providing informed consent
Patients undergoing a primary total hip or knee arthroplasty
Must not have
Patients with contraindications for spinal anesthesia such as: prior lumbar surgery with hardware insertion, elevated intracranial pressure, infection at the site of the procedure, thrombocytopenia or coagulopathy, severe mitral and aortic stenosis and left ventricular outflow obstruction, severe spine pathology (spinal stenosis, spondylolisthesis, spondylosis) with radiculopathy and/or neurogenic claudication, preexisting neurological disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (up to 1 hour after surgery), up to 24 hours.
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to compare how patients recover after joint replacement surgery. The study will look at factors such as hospital stay length, pain levels after surgery, infection rates, implant complications, and the need for
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Who is the study for?
This trial is for individuals with osteoarthritis who are undergoing total joint arthroplasty (TJA). It's important that participants have not been excluded based on specific criteria set by the study, which could include factors like other medical conditions or previous treatments.Check my eligibility
What is being tested?
The trial is comparing general anesthesia versus spinal anesthesia in patients having TJA. The focus is on measuring post-operative outcomes such as hospital stay duration, pain levels, nausea, infection rates at the surgical site, bone fractures near implants, implant dislocation, and necessity for additional surgeries or hospital readmissions.See study design
What are the potential side effects?
Potential side effects from general anesthesia may include nausea, vomiting, sore throat, confusion upon waking up and muscle aches. Spinal anesthesia might cause lower back pain where the needle was inserted, headaches or difficulty urinating.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and agree to the study's procedures.
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Select...
I am having my first hip or knee replacement surgery.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have spinal anesthesia due to certain health issues.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (up to 1 hour after surgery), up to 24 hours.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (up to 1 hour after surgery), up to 24 hours.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Patient Nausea Scores as measured by the Conditioning Scoring Criteria
Change in Patient Pain Scores as measured by the Numeric Rating Pain Scale
Length of hospital stay
+7 moreSecondary study objectives
Length of surgery.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Spinal AnesthesiaExperimental Treatment1 Intervention
Participants in this group will receive spinal anesthesia for TJA for up to 2 hours.
Group II: General AnesthesiaExperimental Treatment1 Intervention
Participants in this group will receive general anesthesia for TJA for up to 2 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Anesthesia
2014
Completed Phase 4
~2780
General Anesthesia
2014
Completed Phase 4
~7010
Find a Location
Closest Location:University of Miami· Miami, FL
Who is running the clinical trial?
University of MiamiLead Sponsor
974 Previous Clinical Trials
420,969 Total Patients Enrolled
Victor H Hernandez, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
333 Total Patients Enrolled