Total Knee Arthroplasty (TKA)Phase 1/2NCT07672301
Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
A Phase 1/2 study testing Total IntraVenous Anesthesia (TIVA), Spinal-Block and Electroencephalogram (EEG) in people with Total Knee Arthroplasty (TKA), run by University of Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- Total IntraVenous Anesthesia (TIVA), Spinal-Block and Electroencephalogram (EEG)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 randomized manner
- No contraindication to either TIVA or spinal anesthesia
Who cannot join
- 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 (3D-CAM) assessments.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Frank T Brown Jr, MA, 773-834-5778, ftbrownjr@uchicagomedicine.org
Zheng (Jimmy) Xie, MD, PhD, 773-753-1880, pager: 1963, JXie@bsd.uchicago.edu
About this study
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).
Secondary Aim: Postoperative comparison of recovery during PostOperative Anesthesia Care Unit (PACU) admission, diagnostic assessment scores; outcomes related to cognition, hemodynamic stability, pain, nausea and vomiting; analysis of IntraOperative electroencephalogram (EEG) monitoring metrics, e.g., total suppression time, average Bi-spectral Index monitor (BIS) value, Spectral Edge Frequency (SEF); ability for Physical Therapy (PT) evaluation prior to discharge; longterm-followup (LTFU), hospital readmission, return to surgery, etc.; adverse event (AE) monitoring.
Read the detailed description
Same-day discharge after total knee arthroplasty (TKA) has become a central goal within Enhanced Recovery After Surgery (ERAS) protocols, particularly in large academic centers. Spinal anesthesia is widely used in this setting and offers advantages through avoidance of general anesthesia-related risks, including airway instrumentation and systemic anesthetic exposure; however, spinal anesthesia may also be associated with prolonged motor blockade, urinary retention, and delayed mobilization, which can hinder same-day discharge in some patients. Rare risks include headache (sometimes called a spinal headache), back soreness, the numbness spreading too high, or the spinal not working well enough and needing conversion to general anesthesia. Very rare but serious risks include infection, bleeding around the spinal cord, or nerve injury.
Total intravenous anesthesia (TIVA) represents an alternative approach that avoids neuraxial anesthesia and its associated risks, including motor weakness and urinary retention, and may reduce postoperative nausea and vomiting. However, TIVA typically requires airway instrumentation and exposure to general anesthetic agents, which carry risks such as sore throat, airway-related discomfort, dental trauma, and potential concerns regarding anesthetic dosing and recovery, particularly in older adults. Processed EEG-guided anesthesia has been proposed as a strategy to optimize anesthetic depth during general anesthesia and potentially reduce overdosing, though its impact on recovery outcomes within contemporary ERAS pathways remains incompletely defined.
This research will address this knowledge gap through a prospective, randomized trial. By comparing same-day discharge rates as the primary outcome-and examining recovery efficiency, postoperative complications, cognitive outcomes, and patient satisfaction as secondary and exploratory measures-this study will provide foundational evidence to inform anesthetic selection. Ultimately, these findings have the potential to refine perioperative care, optimize recovery, and inform future definitive trials and clinical practice guidelines for TKA, improving outcomes for a growing elderly surgical population.
A study comparison of the two anesthesia techniques (TIVA vs spinal-block) in patients undergoing total knee arthroplasty (TKA) is appropriate because anesthetic choice directly influences perioperative recovery, same-day discharge rates, and patient-centered outcomes. Total Knee Arthroplasty (TKA) represents one of the most common and rapidly increasing elective procedures worldwide, particularly among the elderly population at higher risk for adverse outcomes and longer postoperative recovery. A prospective, randomized study design allows for a controlled comparison of the two widely utilized anesthetic techniques within the context of modern ERAS protocols, while also incorporating standardized follow-up to capture both short-term and 90-day long-term outcomes. Beyond individual patient recovery, this research carries broader public health implications: with an aging population and rising demand for TKA, optimizing perioperative pathways that enhance recovery, reduce complications, and support same-day discharge has the potential to decrease healthcare utilization, lower costs, and improve the sustainability of orthopedic care delivery.
Based on our experience caring of these patients over the years, patients with strong preferences or contradictions to one of the two approaches are relatively small (~10-15%). Most patients defer to their anesthesiologists and surgeons to provide the best care plan for them. In the current practice, both anesthesia approaches are widely acceptable care for most patients undergoing TKA and no clear advantages in risk/benefit ratio in same day discharge between methods of anesthesia.
This is a single-center, prospective, randomized clinical trial. Study enrollment will consist of approximately 150-patients set to undergo elective total joint arthroplasty (TKA), at the University of Chicago Medicine (UCM); with 66-evaluable participants randomly assigned to each study arm (TIVA vs Spinal-block). Most TKA-patients are evaluated at least 1-week prior to their surgery by a member of the anesthesia team in the Anesthesia Pre-Operative Clinic (APMC) in preparation for the anesthetic plan to be administered. Eligible patients must meet initial study criteria regarding 'type of surgery' (TKA) and 'discharge plan' (same-day) to be approached regarding their interest in study participation. Potential patients will be contacted on the day of their preoperative evaluation in APMC or via phone following, by a member of the research team with experience consenting patients. Interested patients will:
- have plain language used to describe study details,
- be given time consider the informed consent material and ask questions,
- affirm their understanding of study details,
- be able to consent for themselves.
Patients showing interest by phone will be approached again on the day of surgery in the UCM-preoperative area, where the informed consent form (paper) can be signed, and baseline study diagnostic assessments can be captured. Only after consent and enrollment is confirmed can a patient be randomized to a study arm (TIVA vs spinal block).
Active study participation can last up to 7-days, following surgery, that includes survey assessment interviews to determine postoperative recovery status; with an additional long-term follow-up (LTFU) planned at day-90 via electronic medical record (EMR). Assessments to determine cognitive and physical function will be conducted at specific timepoints via investigator initiated interview (in-person and phone), using validated diagnostic surveys. Patient response will dictate length of time to complete.
Diagnostic Survey Assessments:
- Short Portable Mental Status Questionnaire (SPMSQ)
- 3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
- Numeric Pain Rating Scale (NPRS)
- Numeric Rating Scale (NRS)
Diagnostic Survey Assessment Schedule
Preoperative Baseline (BL):
- SPMSQ (in-person, 3-minutes)
- 3D-CAM (3-minute)
PostOperative (Day-0):
- SPMSQ (in-person, 3-minutes)
- 3D-CAM (in-person, 3-minutes)
- NPRS (in-person, 1-minute)
- NRS (in-person, 1-minute)
PostOperative Day-1 (POD1):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
- NPRS (via phone, 1-minute)
- NRS (via phone, 1-minute)
An 'abnormal' 3D-CAM score in PACU will trigger additional assessment survey completion
PostOperative Day-3 (POD3):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
PostOperative Day-7 (POD7):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
Active participation will conclude either after, POD1 or POD7 (if triggered). Longterm-Followup (LTFU) will be conducted at PostOperative Day-90 (POD90) via electronic medical record (EMR).
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- Total IntraVenous Anesthesia (TIVA), Spinal-Block, Electroencephalogram (EEG)
- Keywords
- Total IntraVenous Anesthesia (TIVA), Spinal block, Delirium - Postoperative, Postoperative Recovery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total IntraVenous Anesthesia (TIVA)Combination product
Also called General Anesthesia, Systemic Anesthesia, TIVA, Deep Sedation
Total IntraVenous Anesthesia - to achieve deep-sedation via chemical analgesic (propofol, dexmedetomidine, fentanyl, hydromorphone); continuous intravenous infusion.
Spinal-BlockCombination product
Also called Regional Anesthesia, Nerve-Block, Field-Block, Local Anesthesia
Spinal-block (mepivacaine 2%, 3.0 mL)
Clinician discretion to administer light-sedation with intravenously infused propofol during surgery.
Electroencephalogram (EEG)Device
Also called EEG, Bi-spectral Index monitor (BIS), BIS, Brain Monitoring
Non-invasive continuous neurological (Neuro) monitoring device, e.g., Bi-spectral (BIS), recording electrical activity of the brain via adhesive scalp electrodes, which transmit neuro-activity during sedation.
| Study group | Role | What they receive |
|---|---|---|
| Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG) | Active comparator | Arm A (TIVA): Induction and maintenance intravenously (propofol, dexmedetomidine, fentanyl, hydromorphone); no volatile agents. Anesthetic depth titration based on clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring. Receives: Combination Product: Total IntraVenous Anesthesia (TIVA); Device: Electroencephalogram (EEG) |
| Arm B - Spinal Block with Electroencephalogram (EEG) | Active comparator | Arm B (Spinal): Single-shot intrathecal mepivacaine-2%, 3.0 milliliters (mL) per institutional standard. Light propofol sedation is permitted at clinician discretion, titrated to comfort and clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring. Receives: Combination Product: Spinal-Block; Device: Electroencephalogram (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Same-Day Discharge (SDD) Rates
Comparison of same-day discharge rates between patients receiving either total intravenous anesthesia (TIVA) or spinal-block anesthesia, during total knee arthroplasty (TKA).
Measured: at PostOperative (Day-0)
Secondary outcomes (9)
Post-Anesthesia Care Unit (PACU) Length of Admission
PostOperative comparison of post-anesthesia care unit (PACU) length of stay (LOS), between both study arms (TIVA vs Spinal-block).
Exact Time Recorded: at PACU admission, physical therapy evaluation, diagnostic survey assessment completion, and at discharge home.
Study-arm timepoints range are averaged and compared.
Measured: at PostOperative (Day-0)
Changes in Short Portable Mental Status Questionnaire (SPMSQ)
The Short Portable Mental Status Questionnaire (SPMSQ) is an interview based validated diagnostic, evaluating basic orientation, memory, current events, and mathematical capabilities (such as counting backward) to determine if a patient requires further, more extensive neurological evaluation.
SPMSQ:
10-question bank
SPMSQ Calculation:
First - subtract incorrect responses from correct
Second - allow for one more error in the scoring if a patient has had a grade school education or less; or one less error if the patient has had education beyond the high school level.
Third - calculate outcome associated with number of errors:
0-2 = normal mental functioning 3-4 = mild cognitive impairment 5-7 = moderate cognitive impairment 8 or more errors: severe cognitive impairment
Measured: at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
Changes in 3-Minute Diagnostic Assessment for Confusion Assessment Method (3D-CAM)
3D-CAM is an interview based bedside tool, screening for, four cardinal features of delirium (i.e., acute changes, inattention, disorganized thinking, altered level of consciousness)
3D-CAM: Patient Interview (10 items): provider asks the patient questions to gauge orientation and attention (e.g., reciting numbers backwards, months of the year backwards, and simple orientation questions)
Observer Ratings (10-12 items): provider records clinical observations and asks collateral sources (family members, nurses, or caregivers) about any sudden changes in the patient's mental status from their baseline
0-20 Scale (Total Score): clinician evaluates cognitive and behavioral items, points are assigned for each positive item, resulting in a score between 0 and 20
Severity Bands: a score of 0 to 1 indicates normal/no delirium, while 2 to 20 indicates increasing levels of delirium severity (subsyndromal to severe delirium)
Measured: at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
Changes in Numeric Rating Scale (NRS) score, Nausea
Nausea, Numeric Rating Scale (NRS), patient-reported diagnostic to evaluate severity of nausea.
Patient rating using a single whole integer from 0 to 10 that best reflects the level nausea.
Nausea NRS rated on a scale from 0 to 10 (where 0 means no nausea and 10 means the worst possible nausea).
Measured: at PostOperative (Day-0) and PostOperative (Day-1)
Monitor changes in Numeric Pain Rating Scale (NPRS) score
Monitoring changes in 'Numeric Pain Rating Scale' (NPRS) diagnostic score to determine effectiveness an anesthesia choice.
The NPRS is a validated self-report diagnostic. Patients verbally select a single whole integer from 0 to 10 that best reflects their 'current' pain level.
Pain number = severity:
0 = No pain 1-3 = Mild pain 4-6 = Moderate pain 7-10 = Severe pain (worst pain imaginable)
Measured: at PostOperative (Day-0) and PostOperative (Day-1)
Satisfaction-Numeric Rating Scale (NRS) score
Satisfaction Numeric Rating Scale (NRS), patient-reported diagnostic to evaluate subjective experiences like pain or distress related to anesthesia care, on a scale from 0 to 10.
Satisfaction NRS: 0 (Completely dissatisfied) to 10 (Completely satisfied).
Measured: at PostOperative (Day-0) and PostOperative (Day-1)
Changes in IntraOperative electroencephalogram (EEG) monitoring
Compare changes in EEG, i.e., suppression, Bi-Spectral Index (BIS), and Spectral Edge Frequency (SEF), during IntraOperative Total Knee Arthroplasty (TKA), between both groups (TIVA vs Spinal block).
Measured: IntraOperative
Adverse Event (AE) monitoring
Monitoring adverse events (AE), such as hemodynamics instability, nausea and vomiting, etc.; or any other events determined probable, possible, or unrelated to the study procedures or protocol.
Study patient safety is monitored by investigators with experience in critical care anesthesia and the clinical research team members responsible for monitoring and reporting events.
Measured: PeriProcedural to Study Completion
Longterm-Followup (LTFU), Outcomes
Compare PostOperative recovery outcomes between arms at 90-day. Electronic Medical Record capture of information related to longterm recovery from surgery and anesthesia, e.g., infection, hospital readmission, return to surgery, Deep vein thrombosis (DVT), myocardial infarction, etc.
Measured: at PostOperative (Day-90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start11 Mar 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (TKA)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, randomized, multiple-arm comparison (66-evaluable, Total intravenous anesthesia vs 66-evaluable Spinal-block).
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zheng Xie, MD, PhD, Principal investigator, University of Chicago, Department of Anesthesia and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672301
- Sponsor's protocol ID
- IRB25-1483
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Per institutional regulation, and at the discretion of Principal Investigator, de-identified data may be shared with researcher(s) at the University of Chicago.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia vs Spinal Anesthesia in Patients Undergoing Unilateral Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07672301
- Acronym / sponsor ID
- IRB25-1483
- Conditions
- Total Knee Arthroplasty (TKA)
- Keywords
- Total IntraVenous Anesthesia (TIVA), Spinal block, Delirium - Postoperative, Postoperative Recovery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Secondary Aim: Postoperative comparison of recovery during PostOperative Anesthesia Care Unit (PACU) admission, diagnostic assessment scores; outcomes related to cognition, hemodynamic stability, pain, nausea and vomiting; analysis of IntraOperative electroencephalogram (EEG) monitoring metrics, e.g., total suppression time, average Bi-spectral Index monitor (BIS) value, Spectral Edge Frequency (SEF); ability for Physical Therapy (PT) evaluation prior to discharge; longterm-followup (LTFU), hospital readmission, return to surgery, etc.; adverse event (AE) monitoring.
Detailed description
Same-day discharge after total knee arthroplasty (TKA) has become a central goal within Enhanced Recovery After Surgery (ERAS) protocols, particularly in large academic centers. Spinal anesthesia is widely used in this setting and offers advantages through avoidance of general anesthesia-related risks, including airway instrumentation and systemic anesthetic exposure; however, spinal anesthesia may also be associated with prolonged motor blockade, urinary retention, and delayed mobilization, which can hinder same-day discharge in some patients. Rare risks include headache (sometimes called a spinal headache), back soreness, the numbness spreading too high, or the spinal not working well enough and needing conversion to general anesthesia. Very rare but serious risks include infection, bleeding around the spinal cord, or nerve injury.
Total intravenous anesthesia (TIVA) represents an alternative approach that avoids neuraxial anesthesia and its associated risks, including motor weakness and urinary retention, and may reduce postoperative nausea and vomiting. However, TIVA typically requires airway instrumentation and exposure to general anesthetic agents, which carry risks such as sore throat, airway-related discomfort, dental trauma, and potential concerns regarding anesthetic dosing and recovery, particularly in older adults. Processed EEG-guided anesthesia has been proposed as a strategy to optimize anesthetic depth during general anesthesia and potentially reduce overdosing, though its impact on recovery outcomes within contemporary ERAS pathways remains incompletely defined.
This research will address this knowledge gap through a prospective, randomized trial. By comparing same-day discharge rates as the primary outcome-and examining recovery efficiency, postoperative complications, cognitive outcomes, and patient satisfaction as secondary and exploratory measures-this study will provide foundational evidence to inform anesthetic selection. Ultimately, these findings have the potential to refine perioperative care, optimize recovery, and inform future definitive trials and clinical practice guidelines for TKA, improving outcomes for a growing elderly surgical population.
A study comparison of the two anesthesia techniques (TIVA vs spinal-block) in patients undergoing total knee arthroplasty (TKA) is appropriate because anesthetic choice directly influences perioperative recovery, same-day discharge rates, and patient-centered outcomes. Total Knee Arthroplasty (TKA) represents one of the most common and rapidly increasing elective procedures worldwide, particularly among the elderly population at higher risk for adverse outcomes and longer postoperative recovery. A prospective, randomized study design allows for a controlled comparison of the two widely utilized anesthetic techniques within the context of modern ERAS protocols, while also incorporating standardized follow-up to capture both short-term and 90-day long-term outcomes. Beyond individual patient recovery, this research carries broader public health implications: with an aging population and rising demand for TKA, optimizing perioperative pathways that enhance recovery, reduce complications, and support same-day discharge has the potential to decrease healthcare utilization, lower costs, and improve the sustainability of orthopedic care delivery.
Based on our experience caring of these patients over the years, patients with strong preferences or contradictions to one of the two approaches are relatively small (~10-15%). Most patients defer to their anesthesiologists and surgeons to provide the best care plan for them. In the current practice, both anesthesia approaches are widely acceptable care for most patients undergoing TKA and no clear advantages in risk/benefit ratio in same day discharge between methods of anesthesia.
This is a single-center, prospective, randomized clinical trial. Study enrollment will consist of approximately 150-patients set to undergo elective total joint arthroplasty (TKA), at the University of Chicago Medicine (UCM); with 66-evaluable participants randomly assigned to each study arm (TIVA vs Spinal-block). Most TKA-patients are evaluated at least 1-week prior to their surgery by a member of the anesthesia team in the Anesthesia Pre-Operative Clinic (APMC) in preparation for the anesthetic plan to be administered. Eligible patients must meet initial study criteria regarding 'type of surgery' (TKA) and 'discharge plan' (same-day) to be approached regarding their interest in study participation. Potential patients will be contacted on the day of their preoperative evaluation in APMC or via phone following, by a member of the research team with experience consenting patients. Interested patients will:
- have plain language used to describe study details,
- be given time consider the informed consent material and ask questions,
- affirm their understanding of study details,
- be able to consent for themselves.
Patients showing interest by phone will be approached again on the day of surgery in the UCM-preoperative area, where the informed consent form (paper) can be signed, and baseline study diagnostic assessments can be captured. Only after consent and enrollment is confirmed can a patient be randomized to a study arm (TIVA vs spinal block).
Active study participation can last up to 7-days, following surgery, that includes survey assessment interviews to determine postoperative recovery status; with an additional long-term follow-up (LTFU) planned at day-90 via electronic medical record (EMR). Assessments to determine cognitive and physical function will be conducted at specific timepoints via investigator initiated interview (in-person and phone), using validated diagnostic surveys. Patient response will dictate length of time to complete.
Diagnostic Survey Assessments:
- Short Portable Mental Status Questionnaire (SPMSQ)
- 3-Minute Diagnostic Confusion Assessment Method (3D-CAM)
- Numeric Pain Rating Scale (NPRS)
- Numeric Rating Scale (NRS)
Diagnostic Survey Assessment Schedule
Preoperative Baseline (BL):
- SPMSQ (in-person, 3-minutes)
- 3D-CAM (3-minute)
PostOperative (Day-0):
- SPMSQ (in-person, 3-minutes)
- 3D-CAM (in-person, 3-minutes)
- NPRS (in-person, 1-minute)
- NRS (in-person, 1-minute)
PostOperative Day-1 (POD1):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
- NPRS (via phone, 1-minute)
- NRS (via phone, 1-minute)
An 'abnormal' 3D-CAM score in PACU will trigger additional assessment survey completion
PostOperative Day-3 (POD3):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
PostOperative Day-7 (POD7):
- SPMSQ (via phone, 3-minutes)
- 3D-CAM (via phone, 3-minutes)
Active participation will conclude either after, POD1 or POD7 (if triggered). Longterm-Followup (LTFU) will be conducted at PostOperative Day-90 (POD90) via electronic medical record (EMR).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, multiple-arm comparison (66-evaluable, Total intravenous anesthesia vs 66-evaluable Spinal-block).
| Arm | Type | Receives |
|---|---|---|
| Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG) | Active comparator | Combination Product: Total IntraVenous Anesthesia (TIVA), Device: Electroencephalogram (EEG)Arm A (TIVA): Induction and maintenance intravenously (propofol, dexmedetomidine, fentanyl, hydromorphone); no volatile agents. Anesthetic depth titration based on clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring. |
| Arm B - Spinal Block with Electroencephalogram (EEG) | Active comparator | Combination Product: Spinal-Block, Device: Electroencephalogram (EEG)Arm B (Spinal): Single-shot intrathecal mepivacaine-2%, 3.0 milliliters (mL) per institutional standard. Light propofol sedation is permitted at clinician discretion, titrated to comfort and clinical responsiveness, hemodynamic and ventilatory parameters, and processed electroencephalogram (EEG) monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total IntraVenous Anesthesia (TIVA)Also: General Anesthesia, Systemic Anesthesia, TIVA, Deep SedationTotal IntraVenous Anesthesia - to achieve deep-sedation via chemical analgesic (propofol, dexmedetomidine, fentanyl, hydromorphone); continuous intravenous infusion. | Combination product | Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG) |
| Spinal-BlockAlso: Regional Anesthesia, Nerve-Block, Field-Block, Local AnesthesiaSpinal-block (mepivacaine 2%, 3.0 mL) Clinician discretion to administer light-sedation with intravenously infused propofol during surgery. | Combination product | Arm B - Spinal Block with Electroencephalogram (EEG) |
| Electroencephalogram (EEG)Also: EEG, Bi-spectral Index monitor (BIS), BIS, Brain MonitoringNon-invasive continuous neurological (Neuro) monitoring device, e.g., Bi-spectral (BIS), recording electrical activity of the brain via adhesive scalp electrodes, which transmit neuro-activity during sedation. | Device | Arm A -Total IntraVenous Anesthesia (TIVA) with Electroencephalogram (EEG), Arm B - Spinal Block with Electroencephalogram (EEG) |
Primary outcome
Compare Same-Day Discharge (SDD) Rates
Time frame: at PostOperative (Day-0)
Comparison of same-day discharge rates between patients receiving either total intravenous anesthesia (TIVA) or spinal-block anesthesia, during total knee arthroplasty (TKA).
9 secondary outcomes
Post-Anesthesia Care Unit (PACU) Length of Admission
Time frame: at PostOperative (Day-0)
Changes in Short Portable Mental Status Questionnaire (SPMSQ)
Time frame: at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
Changes in 3-Minute Diagnostic Assessment for Confusion Assessment Method (3D-CAM)
Time frame: at PreOperative (Baseline), PostOperative (Day-0), PostOperative (Day-1)
Changes in Numeric Rating Scale (NRS) score, Nausea
Time frame: at PostOperative (Day-0) and PostOperative (Day-1)
Monitor changes in Numeric Pain Rating Scale (NPRS) score
Time frame: at PostOperative (Day-0) and PostOperative (Day-1)
Satisfaction-Numeric Rating Scale (NRS) score
Time frame: at PostOperative (Day-0) and PostOperative (Day-1)
Changes in IntraOperative electroencephalogram (EEG) monitoring
Time frame: IntraOperative
Adverse Event (AE) monitoring
Time frame: PeriProcedural to Study Completion
Longterm-Followup (LTFU), Outcomes
Time frame: at PostOperative (Day-90)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. Per institutional regulation, and at the discretion of Principal Investigator, de-identified data may be shared with researcher(s) at the University of Chicago.
Related trials for Total Knee Arthroplasty (TKA)
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Xie, MD, PhD principal investigator
University of Chicago, Department of Anesthesia and Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Total IntraVenous Anesthesia (TIVA), Spinal-Block and Electroencephalogram (EEG) in people with Total Knee Arthroplasty (TKA), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank T Brown Jr, MA (773-834-5778, ftbrownjr@uchicagomedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Same-Day Discharge (SDD) Rates (time frame: at PostOperative (Day-0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.