Comparing general and spinal anesthesia for joint replacement surgery
General Versus Spinal Anesthesia for Total Joint Arthroplasty: A Prospective Randomized Trial
This study is testing whether using general or spinal anesthesia for hip or knee replacement surgery leads to better recovery experiences for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2396 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06747494 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the post-operative outcomes of patients undergoing total joint arthroplasty (TJA) using either general or spinal anesthesia. The research will evaluate various outcomes, including length of hospital stay, post-operative pain levels, incidence of nausea, and rates of surgical site infections, among others. By analyzing these factors, the study seeks to determine which anesthesia method may lead to better recovery experiences for patients undergoing hip or knee replacements.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for primary total hip or knee arthroplasty who can provide informed consent and speak either English or Spanish.
Not a fit: Patients with contraindications for either spinal or general anesthesia, such as severe heart conditions or prior lumbar surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the anesthesia method that leads to improved recovery and fewer complications for patients undergoing joint replacement surgery.
How similar studies have performed: Other studies have explored the effects of different anesthesia methods in orthopedic surgeries, showing varying outcomes, but this specific comparison in TJA is less commonly addressed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing a primary total hip or knee arthroplasty * Subjects must be capable of providing informed consent * English or Spanish speaking Exclusion Criteria: 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 Patients with contraindications for general anesthesia such as: * Congestive heart failure * Severe aortic stenosis * Patient is unable/unwilling to consent * Current pregnancy or women planning on becoming pregnant in the next year, and women who think they might be pregnant, or women who become pregnant during the study period will be removed from the study. * Prisoners
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Victor H Hernandez, MD — University of Miami
- Study coordinator: Victor H Hernandez, MD
- Email: vhh1@med.miami.edu
- Phone: 305-689-5195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.