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Compares treatment options for Total Knee Arthroplasty (TKA)
Official title Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT07672301
What this study is testing
What is Total IntraVenous Anesthesia (TIVA)?
Total IntraVenous Anesthesia (TIVA) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for total knee arthroplasty (tka).
Also referred to as General Anesthesia, Systemic Anesthesia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to compare same-day discharge rates and recovery outcomes across an adult patient population undergoing elective Total Knee Arthroplasty (TKA), and randomized to receive either spinal block anesthesia or Total IntraVenous Anesthesia (TIVA). Primary Aim: assess same-day discharge rates between study arms (TIVA vs spinal).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults aged ≥18 years.
- Scheduled to undergo elective primary total knee arthroplasty (TKA) or robotic total knee arthroplasty (TKA) at the University of Chicago.
- Eligible for same-day discharge (SDD) based on established orthopedic and anesthesia criteria.
- Able to provide written informed consent.
- The ability to comprehend and complete cognitive assessment surveys and questionnaires.
You likely can't join if
- Age \<18 years.
- Patients undergoing revision TKA or procedures other than elective primary TKA.
- Ineligibility for same-day discharge as determined by the surgical or anesthesia team.
- Contraindications to either anesthetic technique (e.g., spinal block anesthesia contraindicated due to coagulopathy, infection at puncture site, or...
- Known allergy or hypersensitivity to study-related medications.
- Significant pre-existing cognitive impairment or dementia that would preclude valid participation in Short Portable Mental Status Questionnaire...
See the full eligibility criteria
- Adults aged ≥18 years.
- Scheduled to undergo elective primary total knee arthroplasty (TKA) or robotic total knee arthroplasty (TKA) at the University of Chicago.
- Eligible for same-day discharge (SDD) based on established orthopedic and anesthesia criteria.
- Able to provide written informed consent.
- The ability to comprehend and complete cognitive assessment surveys and questionnaires.
- Consent to receive either Total IntraVenous Anesthesia (TIVA) or Spinal-block Anesthesia in a assigned by chance manner
- No contraindication to either TIVA or spinal anesthesia
- Age \<18 years.
- Patients undergoing revision TKA or procedures other than elective primary TKA.
- Ineligibility for same-day discharge as determined by the surgical or anesthesia team.
- Contraindications to either anesthetic technique (e.g., spinal block anesthesia contraindicated due to coagulopathy, infection at puncture site, or patient refusal).
- Known allergy or hypersensitivity to study-related medications.
- Significant pre-existing cognitive impairment or dementia that would preclude valid participation in Short Portable Mental Status Questionnaire (SPMSQ), and 3-Minute Diagnostic Assessment for Confusion Assessment Method...
- Severe chronic pain syndromes (e.g., fibromyalgia, centrally mediated pain disorders) that could confound perioperative pain assessment.
- Body mass index (BMI) \> 40.
- Prisoners or other vulnerable populations unable to provide voluntary consent.
- Unable to give appropriate consent or difficult to comprehend and complete cognitive assessment surveys and questionnaires
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.