Total Knee ReplacementNCT05765682
Mepivacaine Vs. Bupivacaine Spinal for TKA
A study testing Mepivacaine Spinal and Bupivacaine Spinal in people with Total Knee Replacement, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Mepivacaine Spinal and Bupivacaine Spinal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 25 Aug 2024
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty
Who cannot join
- Inability to ambulate or impaired motor function in lower extremities prior to surgery
- Contraindication to spinal anesthetic
- Taking over 30mg oxycodone per day (or calculated MME equivalent)
- Subjects that are unable or choose not to give informed consent
- Known preoperative substance abuse
- Pregnant women
- Allergy to all opioids
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Mepivacaine Vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty
This study will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.
- Conditions
- Total Knee Replacement
- Being tested
- Mepivacaine Spinal, Bupivacaine Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mepivacaine SpinalOther
spinal block using 60mg of mepivacaine
Bupivacaine SpinalOther
spinal block using 10mg of bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine Spinal | Active comparator | Mepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space. Receives: Other: Mepivacaine Spinal |
| Bupivacaine Spinal | Active comparator | Isobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space. Receives: Other: Bupivacaine Spinal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time until return of motor function following spinal placement
This will be defined as full strength with both 1) foot plantar and dorsiflexion and 2) hip flexion and 3) knee flexion in the non-operative extremity.
Measured: From anesthesia stop time until 7 days post-op
Secondary outcomes (4)
Ambulation
Time to first ambulation and distance at first ambulation
Measured: from anesthesia stop time until 7 days post-op
Length of Stay
based on anesthesia end time to time discharge order written
Measured: Time from anesthesia end time to when discharge order is written, up to 30 days post-op
Side Effects
Side effects such as Urinary retention, dizziness, symptomatic hypotension, transient neurologic symptoms
Measured: 0-48 hours post spinal placement
Pain Scores
Visual Analog Pain Score 0-100 pain scores at rest, and with movement. A lower pain score means a better outcome.
Measured: Pacu to 48 hours post-spinal placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start13 Mar 2023
- Primary completion23 Aug 2024
- Study completion25 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Clinton F. Pillow, Medical University of South Carolina
- Investigators
- Clinton Pillow, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765682
- Sponsor's protocol ID
- Pro00125382
- Status last verified
- Sep 2024
- First submitted
- 27 Jan 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pillow CF, Brewbaker C, Wolf BJ, Barrett W, Hansen E, Brown A, Crawford D, Wilson SH. Mepivacaine versus bupivacaine spinal anesthesia for return of motor function following total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2025 May 1:rapm-2024-106342. doi: 10.1136/rapm-2024-106342. Online ahead of print.
PubMed 40316299
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepivacaine Vs. Bupivacaine Spinal: Effect on Return of Motor Function, Time to Ambulation, and Length of Stay in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05765682
- Acronym / sponsor ID
- Pro00125382
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 13 Mar 2023 (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 will enroll patients 18-75 years of age who are undergoing elective primary total knee replacement. The patients will be randomized to receive one of two spinal blocks: 1) mepivacaine or 2) bupivacaine. The primary goal is to determine which group arrives at recovery of motor function first. Ultimately, this study will explore if mepivacaine leads to earlier return of motor function and ultimately earlier movement and discharge times following total knee replacement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine Spinal | Active comparator | Other: Mepivacaine SpinalMepivacaine (60 mg: 3ml of 2%) or will be injected into the intrathecal space. |
| Bupivacaine Spinal | Active comparator | Other: Bupivacaine SpinalIsobaric bupivacaine (10mg: 2ml or 0.5%) will be injected into the intrathecal space. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18-75 years of age
- Undergoing elective primary total knee arthroplasty
Key exclusion criteria (7 listed)
- Inability to ambulate or impaired motor function in lower extremities prior to surgery
- Contraindication to spinal anesthetic
- Taking over 30mg oxycodone per day (or calculated MME equivalent)
- Subjects that are unable or choose not to give informed consent
- Known preoperative substance abuse
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 |
|---|---|---|
| Mepivacaine Spinalspinal block using 60mg of mepivacaine | Other | Mepivacaine Spinal |
| Bupivacaine Spinalspinal block using 10mg of bupivacaine | Other | Bupivacaine Spinal |
Primary outcome
Time until return of motor function following spinal placement
Time frame: From anesthesia stop time until 7 days post-op
This will be defined as full strength with both 1) foot plantar and dorsiflexion and 2) hip flexion and 3) knee flexion in the non-operative extremity.
4 secondary outcomes
Ambulation
Time frame: from anesthesia stop time until 7 days post-op
Length of Stay
Time frame: Time from anesthesia end time to when discharge order is written, up to 30 days post-op
Side Effects
Time frame: 0-48 hours post spinal placement
Pain Scores
Time frame: Pacu to 48 hours post-spinal placement
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 19 Sep 2024.
- Derived from this study: PubMed 40316299Pillow CF, Brewbaker C, Wolf BJ, Barrett W, Hansen E, Brown A, Crawford D, Wilson SH. Mepivacaine versus bupivacaine spinal anesthesia for return of motor function following total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2025 May 1:rapm-2024-106342. doi: 10.1136/rapm-2024-106342. Online ahead of print.
- Individual participant dataSharing planned: No
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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.
Clinton Pillow, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mepivacaine Spinal and Bupivacaine Spinal in people with Total Knee Replacement, run by Medical University of South Carolina 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 2 inclusion and 7 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 19 Sep 2024. 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.
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?
Time until return of motor function following spinal placement (time frame: From anesthesia stop time until 7 days post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05765682, which also lists 1 linked publication.
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 19 Sep 2024.