Anesthesia, SpinalPhase 4NCT06291727
Mepivacaine vs Bupivacaine Spinal Anesthesia for TKA
A Phase 4 study testing Mepivacaine and Bupivacaine in people with Anesthesia, Spinal and Arthroplasty, Replacement, Knee, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Spinal, Arthroplasty, Replacement, Knee
- What is being tested?
- Mepivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2024to 1 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Patient is at least 18 years of age who are scheduled for a primary elective TKA.
- Patient can ambulate at least 10 feet independently without human assistance.
- Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II
Who cannot join
- Patients scheduled for bilateral TKAs
- Contraindication to spinal anesthesia
- Revision TKAs
- Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)
- Workers' Compensation patient
- Type I Diabetes
Show all 11Show fewer
- Type II Diabetes requiring insulin medication.
- Pre-operative narcotics use with the exception of tramadol.
- Renal insufficiency (GFR < 60) that may impact post-operative protocol
- Cognitive deficiencies that prevent the patient from providing their own informed consent
- Language barrier preventing completion of study forms in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Patewood Hospital
Greenville, South Carolina, 29615
About this study
Official title: Mepivacaine Versus Bupivacaine Spinal Anesthesia for Same Day Discharge Following Total Knee Arthroplasty
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
Read the detailed description
The purpose of this study is to evaluate the two different spinal anesthesia agents, mepivacaine and bupivacaine, and determine whether there are significant differences in their effects on readiness for same day discharge following a total knee arthroplasty.
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted via telephone or RedCap at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
In this double-blind (patients and assessors) study, the patients will be randomly assigned 1:1 to receive one of the following: mepivacaine 1.5% (4.5ml, 67.5mg) or 2% (3.4ml, 67.5mg), (depending on availability from pharmacy) or hyperbaric bupivacaine 0.75% (1.4ml, 10.5mg) from the spinal kit. Randomization will be computer-generated in RedCap. These doses are the currently the standard doses used for our total knee arthroplasty patients. Patients with a height of 74 inches or greater or with body mass index of 35kg/m2 or greater will be given an extra 0.5ml of local anesthetic. The intraoperative anesthesia team will not be blinded to the group assignment, but patients, surgeons, and assessors are blinded. All patients will receive the standard preoperative multimodal analgesia, consisting of celecoxib 400mg po and acetaminophen 1gm po. Research staff will unblind the study investigators immediately if requested for any potential safety concerns.
- Being tested
- Mepivacaine, Bupivacaine
- Keywords
- knee arthroplasty, spinal anesthesia, same day discharge, mepivacaine, bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Patients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery
BupivacaineDrug
Patients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine | Active comparator | Standard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure Receives: Drug: Mepivacaine |
| Bupivacaine | Active comparator | Standard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Same day discharge rate
Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.
Measured: 24 hours
Secondary outcomes (6)
Post-operative pain score as assessed by numeric rating scale (NRS)
The NRS is a verbal pain scale that is evaluated on a scale of 0-10, with zero being no pain and 10 being 'the worst pain imaginable'. NRS pain scores will be collected while in the post-anesthesia care unit (PACU), at each physical therapy visit until discharge, and at 3 days post-operatively.
Measured: 3 days
Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively
Urinary retention will be evaluated based on whether patient is able to voluntarily void their bladder post-operatively. Time at which patient is able to voluntarily void their bladder will be recorded.
Measured: 24 hours
Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity
Time until return to sensory and motor function will be evaluated based on whether patient is able to plantar or dorsiflex lower extremity after surgery. Motor and sensory function will be considered 'intact' if patient is able perform these motions after surgery. Motor function will be evaluated in the post-anesthesia care unit (PACU) and during hospital stay over the course of 24 hours post-operatively.
Measured: 24 hours
Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively
Nausea and vomiting will be evaluated based on the presence of clinical documentation of episodes of nausea and vomiting during hospital admission over the course of 24 hours.
Measured: 24 hours
Pain Medications as evaluated by medical morphine equivalents
Post-operative medications will be documented by medical morphine equivalents of medications administered during hospital stay. Total medical morphine equivalents over the course of 24 hours post-operatively will be used to capture pain medication usage during admission.
Measured: 24 hours
Patient satisfaction levels as assessed by a 5-item Likert response scale
Patient satisfaction levels will be captured using a 5-item Likert response scale with options of: 'very unsatisfied', 'unsatisfied', 'neutral', 'satisfied', and 'very satisfied' with respect to the type of anesthesia they received during their surgery. Satisfaction will be evaluated at Day 3 post-operative follow-up call.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start16 Feb 2024
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, SpinalStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to one of two groups; one receiving Mepivacaine spinal anesthesia and the other receiving Bupivacaine spinal anesthesia for total knee arthroplasty (TKA).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291727
- Sponsor's protocol ID
- Prisma Upstate
- Status last verified
- Aug 2025
- First submitted
- 16 Feb 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepivacaine Versus Bupivacaine Spinal Anesthesia for Same Day Discharge Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06291727
- Acronym / sponsor ID
- Prisma Upstate
- Keywords
- knee arthroplasty, spinal anesthesia, same day discharge, mepivacaine, bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 4 Mar 2024 (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.
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
Detailed description
The purpose of this study is to evaluate the two different spinal anesthesia agents, mepivacaine and bupivacaine, and determine whether there are significant differences in their effects on readiness for same day discharge following a total knee arthroplasty.
This study is a prospective, double-blind prospective randomized controlled trial comparing mepivacaine and bupivacaine spinal anesthesia for same-day discharge readiness following a unilateral primary elective TKA procedure.
Study data will be collected during the patient's hospital stay for their TKA procedure, and the primary outcome of same-day discharge readiness will be assessed the day of surgery. Patients will also be contacted via telephone or RedCap at Day 3 post-op to assess for any complications, current level of pain, and pain medication utilization.
In this double-blind (patients and assessors) study, the patients will be randomly assigned 1:1 to receive one of the following: mepivacaine 1.5% (4.5ml, 67.5mg) or 2% (3.4ml, 67.5mg), (depending on availability from pharmacy) or hyperbaric bupivacaine 0.75% (1.4ml, 10.5mg) from the spinal kit. Randomization will be computer-generated in RedCap. These doses are the currently the standard doses used for our total knee arthroplasty patients. Patients with a height of 74 inches or greater or with body mass index of 35kg/m2 or greater will be given an extra 0.5ml of local anesthetic. The intraoperative anesthesia team will not be blinded to the group assignment, but patients, surgeons, and assessors are blinded. All patients will receive the standard preoperative multimodal analgesia, consisting of celecoxib 400mg po and acetaminophen 1gm po. Research staff will unblind the study investigators immediately if requested for any potential safety concerns.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to one of two groups; one receiving Mepivacaine spinal anesthesia and the other receiving Bupivacaine spinal anesthesia for total knee arthroplasty (TKA).
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine | Active comparator | Drug: MepivacaineStandard dose of mepivacaine anesthesia (1.5% or 2%) for total knee arthroplasty procedure |
| Bupivacaine | Active comparator | Drug: BupivacaineStandard dose of hyperbaric bupivacaine anesthesia (0.75%) for total knee arthroplasty procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is at least 18 years of age who are scheduled for a primary elective TKA.
- Patient can ambulate at least 10 feet independently without human assistance.
- Patient must be a candidate for same day discharge as determined by American Society of Anesthesiologists (ASA) Physical Status Classification I and II
Key exclusion criteria (11 listed)
- Patients scheduled for bilateral TKAs
- Contraindication to spinal anesthesia
- Revision TKAs
- Allergy or contraindication to NSAIDs (e.g. chronic anti-coagulant use)
- Workers' Compensation patient
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 |
|---|---|---|
| MepivacainePatients will be administered a standard dose of mepivacaine 1.5% (4.5ml, 67.5mg) for total knee arthroplasty prior to surgery | Drug | Mepivacaine |
| BupivacainePatients will be administered a standard dose of 0.75% hyperbaric bupivacaine (1.4ml, 10.5mg) for total knee arthroplasty prior to surgery | Drug | Bupivacaine |
Primary outcome
Same day discharge rate
Time frame: 24 hours
Whether a patient is discharged the same day their surgery occurred, or if they were required to stay overnight following surgery.
6 secondary outcomes
Post-operative pain score as assessed by numeric rating scale (NRS)
Time frame: 3 days
Urinary retention as assessed by time at which patient can voluntarily void bladder post-operatively
Time frame: 24 hours
Return of sensory and motor function as assessed by ability of patient to plantar and dorsiflex lower extremity
Time frame: 24 hours
Post-operative nausea and vomiting as assessed by clinical documentation of nausea and vomiting post-operatively
Time frame: 24 hours
Pain Medications as evaluated by medical morphine equivalents
Time frame: 24 hours
Patient satisfaction levels as assessed by a 5-item Likert response scale
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mepivacaine and Bupivacaine in people with Anesthesia, Spinal and Arthroplasty, Replacement, Knee, run by Prisma Health-Upstate 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 3 inclusion and 11 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: finished, as of the sponsor's last update on 28 Aug 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Same day discharge rate (time frame: 24 hours). 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 28 Aug 2025.