Knee OsteoarthritisPhase 2/3NCT03838874
Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
A Phase 2/3 study testing Low-Dose Bupivacaine and Mepivacaine in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery. Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis
- What is being tested?
- Low-Dose Bupivacaine and Mepivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2019to 29 Oct 2019
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet criteria of a status I-III in the ASA Physical Status Classification System: I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)
- Unilateral primary TKA or THA
- 18+ years of age
- Able to provide informed consent
Who cannot join
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- Chronic opioid use (>1 mos) with OME >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- Body mass index (BMI) > 45 kg/m2
- Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever)
- Major systemic medical comorbidities such as:
- Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
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- Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
- Contraindication to spinal anesthesia technique (e.g., known spinal stenosis, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame*). *Per ASRA guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held for at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin (Lovenox) with doses > 1 mg/kg held for close to 24 hours.
- Known to be currently pregnant or actively breastfeeding. Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. Female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. Urine sample be collected pre-procedurally.
- Impaired cognition
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Being tested
- Low-Dose Bupivacaine, Mepivacaine
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose BupivacaineDrug
10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
MepivacaineDrug
70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Bupivacaine | Active comparator | Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Receives: Drug: Low-Dose Bupivacaine |
| Mepivacaine | Active comparator | Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Receives: Drug: Mepivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return of Lower Extremity Motor Function
Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.
Measured: Post surgery, approximately 1 day
Secondary outcomes (8)
Post-Anesthesia Care Unit (PACU) Length of Stay
Number of minutes subjects were admitted to PACU following the surgical procedure
Measured: Time of discharge, approximately 1-2 days
Hospital Length of Stay
Number days subjects were admitted to the hospital following the surgical procedure
Measured: Time of discharge, approximately 1-2 days
Maximum Pain Score
Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
Measured: 24 hours following the surgical procedure
Median Pain Score
Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
Measured: 24 hours following the surgical procedure
Discharge Pain Score
Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.
Measured: Time of discharge, approximately 1-2 days
Orthostatic Hypotension
Number of participants to experience orthostatic hypotension following the surgical procedure.
Measured: Time of discharge, approximately 1-2 days
Urinary Retention
Number of participants to experience urinary retention follow the surgical procedure.
Measured: Time of discharge, approximately 1-2 days
Transient Neurologic Symptoms
Number of participants to report transient neurologic symptoms
Measured: One week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start25 Feb 2019
- Primary completion29 Oct 2019
- Study completion29 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew P Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838874
- Sponsor's protocol ID
- 18-008635
- Status last verified
- Jul 2021
- First submitted
- 11 Feb 2019
- Last updated
- 12 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03838874
- Acronym / sponsor ID
- 18-008635
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Oct 2019 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Posted 12 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Bupivacaine | Active comparator | Drug: Low-Dose BupivacaineSubjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. |
| Mepivacaine | Active comparator | Drug: MepivacaineSubjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet criteria of a status I-III in the ASA Physical Status Classification System: I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)
- Unilateral primary TKA or THA
- 18+ years of age
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- Chronic opioid use (>1 mos) with OME >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- Body mass index (BMI) > 45 kg/m2
- Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever)
- Major systemic medical comorbidities such as:
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 |
|---|---|---|
| Low-Dose Bupivacaine10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic | Drug | Low-Dose Bupivacaine |
| Mepivacaine70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic | Drug | Mepivacaine |
Primary outcome
Time to Return of Lower Extremity Motor Function
Time frame: Post surgery, approximately 1 day
Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.
8 secondary outcomes
Post-Anesthesia Care Unit (PACU) Length of Stay
Time frame: Time of discharge, approximately 1-2 days
Hospital Length of Stay
Time frame: Time of discharge, approximately 1-2 days
Maximum Pain Score
Time frame: 24 hours following the surgical procedure
Median Pain Score
Time frame: 24 hours following the surgical procedure
Discharge Pain Score
Time frame: Time of discharge, approximately 1-2 days
Orthostatic Hypotension
Time frame: Time of discharge, approximately 1-2 days
Urinary Retention
Time frame: Time of discharge, approximately 1-2 days
Transient Neurologic Symptoms
Time frame: One week post-operative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Matthew P Abdel, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Low-Dose Bupivacaine and Mepivacaine in people with Knee Osteoarthritis and Hip Osteoarthritis, run by Mayo Clinic 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 4 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: finished, as of the sponsor's last update on 12 Aug 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to Return of Lower Extremity Motor Function (time frame: Post surgery, approximately 1 day). 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 12 Aug 2021.