Anesthesia, SpinalPhase 4NCT02980926
Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty
A Phase 4 study testing Mepivacaine and Bupivacaine in people with Anesthesia, Spinal and Arthroplasty, Replacement, Knee, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Spinal, Arthroplasty, Replacement, Knee, Pain Management
- What is being tested?
- Mepivacaine and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Mar 2017
- 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 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients undergoing primary total knee arthroplasty
Who cannot join
- Chronic opioid users
- Unable to give informed consent
- Forego the use of a foley catheter
- Those with hypersensitively to amide local anesthetics or opioids
- Those with contraindications to spinal anesthesia
- Conversion to general anesthesia will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford West Bloomfield
West Bloomfield, Michigan, 48322
About this study
Official title: Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial
The purpose of this study is to determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.
Read the detailed description
Different medications last for different amounts of time and can be changed depending on the length of the procedure. A short acting spinal is generally used for procedures lasting less than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes. These medications not only block the signals that travel along the pain nerves, they also prevent the signals that tell the patients muscles to move. This means that after a total knee replacement a patient may delayed in their ability to get up and start walking early after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary embolism and death. Ambulating early is also important to prevent loss of strength, constipation, pneumonia and urinary retention.
- Conditions
- Anesthesia, Spinal, Arthroplasty, Replacement, Knee, Pain Management, Early Ambulation, Ambulatory Surgical Procedures
- Being tested
- Mepivacaine, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MepivacaineDrug
Also called CAS Number: 96-88-8, Carbocaine
This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.
BupivacaineDrug
Also called Sensorcaine, Marcaine, CAS 38396-39-3
This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.
| Study group | Role | What they receive |
|---|---|---|
| Mepivacaine Spinal Anesthetic | Experimental | Mepivacaine 3 mL intrathecal injection of 2% solution Receives: Drug: Mepivacaine |
| Bupivacaine Spinal Anesthetic | Active comparator | Bupivacaine 12 mg of 8.25% solution Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Return of motor and sensory function
Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.
Measured: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.
Secondary outcomes (7)
Pain
visual analog scale from 0 - 10
Measured: Entire hospital admission. No data will be recorded after 96 hours.
Pain
morphine equivalent consumption
Measured: Hospital admission, maximum of 96 hours.
Time to urination
The total time between the administration of spinal anesthesia to the first episode of spontaneous urination will be recorded. Patients who require greater than 6 hours to urinate independently are followed per hospital protocol with serial bladder scans and straight catheterization for urinary retention as needed. Patients who exceed 6 hours to urinate will be defined as having urinary retention.
Measured: 24 hours maximum from time of spinal.
Urinary retention
The number of straight catheterization and foley placements will be recorded as well.
Measured: Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.
Length of stay
Length of stay
Measured: Hospital admission maximum of 96 hours.
Time to discharge readiness.
Time from admission to discharge readiness as assessed by physical therapy.
Measured: Hospital admission maximum of 96 hours.
Transient Neurologic Symptoms
Any episodes of transient radiating pain in the buttocks and thigh will be recorded in the hospital charts during routine post operative rounds. This is also be discussed at the first follow up visit scheduled 2 weeks after surgery.
Measured: Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017
- Study completionMar 2017
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.
- More trials run by Henry Ford Health SystemThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Chad Mahan, M.D., Henry Ford Health System
- Investigators
- Jason Davis, MD, Principal investigator, Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980926
- Sponsor's protocol ID
- #10455
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2016
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02980926
- Acronym / sponsor ID
- #10455
- Conditions
- Anesthesia, Spinal, Arthroplasty, Replacement, Knee, Pain Management, Early Ambulation, Ambulatory Surgical Procedures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- 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 determine if a shorter-acting spinal anesthetic called mepivacaine has advantages over a longer-acting medication called bupivacaine.
Detailed description
Different medications last for different amounts of time and can be changed depending on the length of the procedure. A short acting spinal is generally used for procedures lasting less than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes. These medications not only block the signals that travel along the pain nerves, they also prevent the signals that tell the patients muscles to move. This means that after a total knee replacement a patient may delayed in their ability to get up and start walking early after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary embolism and death. Ambulating early is also important to prevent loss of strength, constipation, pneumonia and urinary retention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mepivacaine Spinal Anesthetic | Experimental | Drug: MepivacaineMepivacaine 3 mL intrathecal injection of 2% solution |
| Bupivacaine Spinal Anesthetic | Active comparator | Drug: BupivacaineBupivacaine 12 mg of 8.25% solution |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients undergoing primary total knee arthroplasty
Key exclusion criteria (6 listed)
- Chronic opioid users
- Unable to give informed consent
- Forego the use of a foley catheter
- Those with hypersensitively to amide local anesthetics or opioids
- Those with contraindications to spinal anesthesia
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 |
|---|---|---|
| MepivacaineAlso: CAS Number: 96-88-8, CarbocaineThis is a shorter acting spinal anesthetic as compared to the current standard of care at this institution. | Drug | Mepivacaine Spinal Anesthetic |
| BupivacaineAlso: Sensorcaine, Marcaine, CAS 38396-39-3This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug. | Drug | Bupivacaine Spinal Anesthetic |
Primary outcome
Return of motor and sensory function
Time frame: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.
Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.
7 secondary outcomes
Pain
Time frame: Entire hospital admission. No data will be recorded after 96 hours.
Pain
Time frame: Hospital admission, maximum of 96 hours.
Time to urination
Time frame: 24 hours maximum from time of spinal.
Urinary retention
Time frame: Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.
Length of stay
Time frame: Hospital admission maximum of 96 hours.
Time to discharge readiness.
Time frame: Hospital admission maximum of 96 hours.
Transient Neurologic Symptoms
Time frame: Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal
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 27 Mar 2017.
- 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.
Jason Davis, MD principal investigator
Surgeon
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 Henry Ford Health System 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 1 inclusion and 6 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 27 Mar 2017. 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?
Return of motor and sensory function (time frame: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.). 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 27 Mar 2017.